WO2019177973A1 - Methods for assessing suicidality - Google Patents

Methods for assessing suicidality Download PDF

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Publication number
WO2019177973A1
WO2019177973A1 PCT/US2019/021618 US2019021618W WO2019177973A1 WO 2019177973 A1 WO2019177973 A1 WO 2019177973A1 US 2019021618 W US2019021618 W US 2019021618W WO 2019177973 A1 WO2019177973 A1 WO 2019177973A1
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WIPO (PCT)
Prior art keywords
patient
rating
questions
series
clinician
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PCT/US2019/021618
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French (fr)
Inventor
James Randall OWEN
Srdjan R. STANKOVIC
Erin Pennock FOFF
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Acadia Pharmaceuticals Inc.
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Publication of WO2019177973A1 publication Critical patent/WO2019177973A1/en

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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment

Definitions

  • kits for assessing a patient’s suicidality are provided herein. Also provided herein are methods for including or excluding a patient from a clinical study group.
  • C-SSRS Columbia-Suicide Severity Rating Scale
  • provided herein are methods for assessing a patient’s suicidality.
  • the methods for assessing a patient’s suicidality comprise:
  • steps (a)-(e) are performed on a first interview.
  • the methods further comprise on a second interview:
  • the methods further comprise:
  • the methods for including or excluding a patient from a clinical study group comprise:
  • the patient is a patient having dementia.
  • the patient is a patient having Alzheimer’s dementia, Parkinson’s disease dementia, Lewy Body dementia, frontotemporal dementia, and vascular dementia, or any combination thereof.
  • the patient is a patient having or at risk of having dementia- related psychosis.
  • the patient is a patient having or at risk of having psychosis associated with a neurodegenerative disease or disorder.
  • the patient is a patient having or at risk of having
  • the patient is a patient having or at risk of having
  • the patient is a patient having or at risk of having agitation and aggression in Alzheimer’s dementia.
  • a scale for assessing a patient’s suicidality said scale to conduct a clinical assessment of the patient’s suicidality according to a Global Clinician Assessment of Suicidality (GCAS) scale.
  • GCAS Global Clinician Assessment of Suicidality
  • instructions of the scale comprise:
  • the instructions further comprise recommended actions in view a clinician’s rating of 3 or greater on the GCAS scale, said rating of 3 or greater indicates an increased suicidality in the patient.
  • the methods comprise:
  • the steps (a)-(e) are performed on a first interview.
  • the patient is a patient having dementia.
  • the patient is a patient having Alzheimer’s dementia, Parkinson’s disease dementia, Lewy Body dementia, frontotemporal dementia, and vascular dementia, or any combination thereof.
  • a patient having dementia is a patient having impairment of one or more of the core mental function such as memory, communication and language, ability to focus and pay attention, reasoning and judgment, and visual perception.
  • a patient having dementia is a patient significantly impaired in at least two of the core mental functions, i.e. memory, communication and language, ability to focus and pay attention, reasoning and judgment, and visual perception.
  • Suicidality providing a scale of assessing a patient’s suicidality, for example in a patient having dementia.
  • GCAS provides a tool for assessing the patient’s suicidality, such as a tool to assessing the severity of suicidal symptoms, such as suicidal ideation and/or suicide attempts.
  • GCAS may be used as a threshold, e.g. to assess if a patient should be included of excluded from a clinical study group.
  • GCAS may be used to assess a patient’s suicidality over time, i.e. rating if a patient is getting more or less suicidal.
  • the above method further comprising on a second interview:
  • the clinician’s rating of 3 or greater on the GCAS scale indicates an increased suicidality in the patient. In some embodiments, the clinician’s rating of 4 on the GCAS scale indicates an increased suicidality. Additionally, a clinician’s rating increasing from e.g. 0 to 2 over a period of time also implies an increased suicidal ideation or suicidal action, or increased suicidality and may warrant further evaluation of the patient.
  • a clinician’s rating changing over time i.e. from 0 to 2 over 3 months may be an indication of increased suicidality.
  • the methods further comprise: (f) communicating that the patient has been assessed to have an increased suicidality to a health care professional if the clinician’s rating using the GCAS scale is 3 or greater, optionally providing treatment of the suicidality.
  • the methods further comprise and alternative assessment, where a patient in a first rating obtained: (f) communicating that the patient has been assessed to have an increased suicidality to a health care professional if the clinician’s rating using the GCAS scale is 3 or greater, optionally providing treatment of the suicidality.
  • the methods comprise:
  • the patient is a human that has or is at risk for a disease, disorder or condition provided herein.
  • the patient has or is at risk of having a disease, disorder or condition selected from the group of dementia, Alzheimer’s dementia, Parkinson’s disease, e.g. Dementia in Parkinson’s disease having dementia, depression, schizophrenia and psychosis.
  • the patient has or is at risk of having dementia, such as Alzheimer’s dementia, Parkinson’s disease dementia, Lewy Body dementia, frontotemporal dementia, and vascular dementia, or any combination thereof.
  • the patient has or is at risk of having a neurodegenerative disease.
  • the patient has or is at risk of having dementia-related psychosis.
  • the patient has or is at risk of having psychosis associated with a neurodegenerative disease. In certain embodiments, the patient has or is at risk of having Alzheimer’s dementia. In certain embodiments, the patient has or is at risk of having Parkinson’s disease. In certain embodiments, the patient has or is at risk of having agitation and aggression in Alzheimer’s dementia.
  • the patient is administered an agent for the treatment of psychosis associated with a neurodegenerative disease or disorder.
  • the patient is administered an agent for the treatment of Parkinson’s disease psychosis.
  • the patient is administered an agent for the treatment of Alzheimer’s disease psychosis.
  • Exemplary agents used for the treatment of Alzheimer’s disease psychosis include, but are not limited to, memantine, cholinesterase inhibitors, tacrine, donepezil, and rivastigmine.
  • the patient is administered pimavanserin.
  • the age of the patient is 45 years or older, 50 years or older, or 55 years or old, or 60 years or older, or 65 years or older, or 70 years or older at baseline. In another embodiment, the age of the patient is 50 years or older.
  • the cognitive status of the patient is not impaired.
  • the cognitive status patient is determined by the Mini-Mental State Examiner (MMSE) score.
  • MMSE Mini-Mental State Examiner
  • the patient is a candidate to be enrolled in a clinical trial study group. In certain embodiment, the patient is enrolled in a clinical trial study group.
  • the interview is performed in person. In certain embodiments, the interview is performed in person.
  • the interview is performed in person, e.g. during a visit to the clinician responsible for the rating of patient.
  • the interview is performed using an exchange system capable of exchanging information between individuals.
  • the interview is performed by asking questions recorded on a tangible media and then by recording the patient’s response and/or the caregiver’s response on a tangible media.
  • tangible media can include, for example, an audio tape or on a video tape.
  • a clinician asks a patient questions using a video streaming interface or system.
  • the second interview is at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 weeks after the first interview. In certain embodiments, the second interview is 1 or 2 weeks after the first interview. In certain embodiments, the second interview is 2 weeks after the first interview.
  • multiple follow-up interviews are performed after the first interview. In certain embodiments, multiple follow-up interviews are performed at a fixed interval of time period. In one embodiment, multiple follow-up interviews are performed every 1, 2, 3, 4, 5, 6, 7, or 8 weeks after the first interview.
  • each item of the scale is scored as a whole number, not a fraction.
  • the clinician rates after interviewing the patient and caregiver.
  • the clinician’s rating is the primary rating of GCAS, and the score by which decisions are made about the patient’s suicidality.
  • the patient’s rating is a rating assigned to the patient by the clinician asking questions to the patient in the interview.
  • the patient’s rating is a rating assigned to the patient by the patient’s caregiver.
  • the patient’s rating is a self-reported rating by the patient.
  • the patient’s rating is a rating assigned by an expert system.
  • the patient’s rating is based on the patient’s response to the series of questions on his or her thoughts on self- harm and suicide.
  • the caregiver’s rating is the rating assigned to the patient by the clinician asking questions to the caregiver in the interview. In one preferred embodiment, the caregiver’s rating is the rating assigned to the patient by the caregiver. In yet another embodiment, the caregiver’s rating is a rating assigned by an expert system. In certain embodiments, the caregiver’s rating is based on the patient’s response to the series of questions on the patient’s thoughts on self-harm and suicide.
  • each item of the scale is scored as a whole number, not a fraction, and the clinician rates after interviewing the patient and caregiver, and the clinician’s rating is the primary rating of GCAS, and the score by which decisions are made about the patient’s suicidality.
  • a clinician rating of 3 or greater on the GCAS scale indicates active suicidal ideation or suicidal action.
  • the series of questions on the patient’s thoughts on self-harm and suicide are simple, direct and open-ended questions. In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide further comprise additional probing questions when appropriate. In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide comprise questions similar to those in other scales. In one embodiment, the series of questions on the patient’s thoughts on self-harm and suicide comprise questions similar to those used in the Clinical Global Impression (CGI) scale. In another embodiment, the series of questions on the patient’s thoughts on self-harm and suicide comprise questions similar to those used in the improved Clinical Global Impression (i-CGI) scale.
  • CGI Clinical Global Impression
  • i-CGI improved Clinical Global Impression
  • the additional probing questions comprise, for example, one or more following questions:
  • the series of questions on the patient’s thoughts on self-harm and suicide comprise, for example, one or more of the following questions:
  • the series of questions on the patient’s thoughts on self-harm and suicide comprise, for example, one or more of the following questions:
  • At least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 questions are asked as the series of questions on the patient’s thoughts on self-harm and suicide.
  • the caregiver is asked a similar series of questions about the patient’s thoughts on self-harm and suicide to those asked to the patient.
  • the series of questions on the patient’s thoughts on self-harm and suicide during the first interview is about the patient’s thoughts on self-harm and suicide over the 3 months prior to the first interview.
  • the series of questions on the patient’s thoughts on self-harm and suicide during the first interview is about the patient’s thoughts on self-harm and suicide over the lifetime prior to the first interview.
  • the series of questions on the patient’s thoughts on self-harm and suicide during the first interview is about the patient’s thoughts on self-harm and suicide over the 3 months prior to the first interview and over the lifetime prior to the first interview.
  • the series of questions on the patient’s thoughts on self-harm and suicide during the second interview is about the patient’s thoughts on self-harm and suicide since the first interview.
  • the series of questions on the patient’s thoughts on self-harm and suicide during the second interview is about the patient’s thoughts on self-harm and suicide during a period of time between the first interview and the second interview.
  • the series of questions on the patient’s thoughts on self-harm and suicide during the second interview is about the patient’s current thoughts on self-harm and suicide during the second interview.
  • the patient and the caregiver are both interviewed in the interview.
  • the patient’s rating using the GCAS scale and the caregiver’s rating of the patient using the GCAS scale are recorded prior to determination of the clinician’s rating of the patient using the GCAS scale.
  • the determination of clinician’s rating of the patient using the GCAS scale takes into account all available information including the patient’s response and the caregiver’s response to the series of questions on the patient’s thoughts on self-harm and suicide.
  • the determination of clinician’s rating of the patient using the GCAS scale takes into account adverse event reporting.
  • the clinician’s rating on the second interview is independent of the clinician’s rating on the first visit.
  • the clinician’s rating on the second interview takes into account of the information of the first interview including, for example, the patient’s response, the caregiver’s response, and/or the clinician’s rating during the first interview.
  • a primary assessment is recorded in a case report form (CRF).
  • the clinician’s rating is the primary assessment.
  • the patient’s rating, the caregiver’s rating and the clinician’s rating are recorded in the CRF. In another embodiment, only the clinician’s rating is recorded in the CRF.
  • a scale for assessing a patient’s suicidality said scale to conduct a clinical assessment of the patient’s suicidality according to a Global Clinician Assessment of Suicidality (GCAS) scale.
  • GCAS Global Clinician Assessment of Suicidality
  • instructions of the scale comprise:
  • the instructions further comprise recommended actions in view a clinician’s rating of 3 or greater on the GCAS scale, said rating of 3 or greater indicates an increased suicidality in the patient.
  • the term“patient” refers to a human.
  • the patient has or is at risk for a disease, disorder or condition provided herein.
  • the patient has or is at risk for a disease, disorder or condition wherein the disease, disorder or condition, or a symptom thereof, can be treated, prevented or ameliorated by the administration of
  • the patient has a disease, disorder or condition wherein the disease, disorder or condition, or a symptom thereof, can be treated, prevented or ameliorated by the administration of pimavanserin tartrate salt.
  • the term“ask” or“asking” refer to ask one or more questions to elicit a response in personal or through an exchange system capable of exchanging information between individuals.
  • a clinician asks a patient questions in person during the patient’s visit to the clinician.
  • a clinician asks a patient questions recorded on a tangible media, for example, questions recorded on an audio tape or on a video tape.
  • a clinician asks a patient questions using a video streaming interface.
  • the term“a series of questions on his or her thoughts on self-harm and suicide” refers to questions that include questions about a human’s thoughts about a wish to be dead or not alive, or wish to fall asleep and not wake-up; about nonspecific thoughts of wanting end his or her life or commit suicide (e.g.,“I’ve thought about killing myself) without general thought of ways to kill oneself/associated methods, intent, or plan; about thought of at least one method of suicide; about active suicidal thoughts of killing oneself and about intent to act on such thought; and about thoughts of killing oneself with details of plan fully or partially worked out and about some intent to carry it out.
  • the questions are similar to questions used in the Clinical Global Impressions (CGI) scale.
  • the term“lifetime” refers to the duration of the existence of a human.
  • the terms“record” or“recording” refer to describe the documentary results of an examination or interview and storage of such documentary results on a tangible medium.
  • information can be recorded on a paper or any electronic media including, among other things, word processor documents, web browser pages, pictures, tables, charts, video clips, audio clips, multi-media presentations, etc.
  • the term“clinician” refers to an individual who has knowledge of assessment and reporting of suicidality, with an appropriate clinical background for making a clinical judgment.
  • the clinician is a licensed professional, for example, a physician, psychologist, social worker, behavior therapist, nurse practitioner, or psychiatric nurse.
  • the clinician is an investigator in a clinical study.
  • the term“caregiver” refers to the act of providing assistance and support to a human who has physical, psychological, or developmental needs.
  • a caregiver is a person who provides assistance and support to family members or acquaintances who has physical, psychological, or developmental needs.
  • a caregiver is a paid member of a person's social network who helps him or her with activities of daily living.
  • Caring for others generally takes on three forms: instrumental, emotional, and informational caring.
  • Instrumental help includes activities such as shopping for someone who is disabled or cleaning for an elderly parent.
  • Caregiving also involves a great deal of emotional support, which may include listening, counseling, and companionship.
  • part of caring for others may be informational in nature, such as learning how to alter the living environment of someone in the first stages of dementia.
  • Typical duties of a caregiver might include taking care of someone who has a chronic illness or disease; managing medications or talking to doctors and nurses on someone's behalf; helping to bathe or dress someone who is frail or disabled; or taking care of household chores, meals, or bills for someone who cannot do these things alone.
  • the term“patient’s suicidality” refers to the evaluation of a patient’s likelihood of suicide including suicidal ideation and behavior, which is reflected or measured using a Global Clinician Assessment of Suicidality (GCAS) scale.
  • GCAS Global Clinician Assessment of Suicidality
  • the GCAS scale rates a patient’s suicidality on a 0-4 scale, where a rating of 0 represents absence of suicidal ideation or behavior; a rating of 1 represents that the patients feels life is not worth living; a rating of 2 represents that the patient wishes he/she were dead or any thoughts of possible death to self; a rating of 3 represents that the patient has suicidal ideas or gesture; and a rating of 4 represents the patient attempts at suicide.
  • Neurodegenerative disease or disorder refers to a disease or disorder selected from the group consisting of Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, frontotemporal lobar degeneration associated with protein TDP-43 (FTLD-TDP), dementia with lewy bodies (DLB), vascular dementia, amyotrophic lateral sclerosis (ALS), and other neurodegenerative related dementias due to changes in the brain caused by ageing, disease or trauma; or spinal cord injury.
  • FTLD-TDP frontotemporal lobar degeneration associated with protein TDP-43
  • DLB dementia with lewy bodies
  • vascular dementia dementia with lewy bodies
  • ALS amyotrophic lateral sclerosis
  • other neurodegenerative related dementias due to changes in the brain caused by ageing, disease or trauma; or spinal cord injury.
  • Expert system refers to a computer program executing on a computer that implements abductive reasoning or logic configured to determine a rating based on information input. The determination may be based on specific criteria set beforehand and driven by events. For instance, the computer program may be configured to determine a rating score of a patient based on the response information the patient provide and also based on the specific criteria set by a clinician.
  • Selected patient candidates may be home-cared by his or her spouse, which in this case the caregiver will be the patient candidate’s spouse.
  • the patient candidate is the husband and his spouse is the caregiver.
  • a patient candidate and his spouse will be requested to visit a clinician for a first interview (day 1), in which the clinician will ask the patient candidate a series of questions such as those exemplified herein.
  • the clinician will ask the patient candidate, for example, that“In your lifetime and in the past three months, do you feel that life is not worth living?”“In your lifetime and in the past three months, do you think about killing yourself?”“In your lifetime and in the past three months, have you tried to hurt (or kill) yourself?”“In your lifetime and in the past three months, how do you see the future?”
  • the clinician will give a patient’s rating based on the patient’s response about his or her thoughts on self-harm and suicide on a scale of 0-4 on a Global Clinician Assessment of Suicidality (GCAS):
  • GCAS Global Clinician Assessment of Suicidality
  • the clinician may report a patient’s rating of 1.
  • the clinician will record the patient’s rating of 1 on a case report form (CRF) for a first visit.
  • CRF case report form
  • the clinician may ask the patient candidate’s spouse appropriate questions such as“In your husband’s lifetime and in the past three months, does your husband feel that life is not worth living?”“In your husband’s lifetime and in the past three months, does your husband think about killing himself?”“In your husband’s lifetime and in the past three months, has your husband tried to hurt (or kill) himself?”“In your husband’s lifetime and in the past three months, how does your husband see the future?”
  • GCAS Global Clinician Assessment of Suicidality
  • the clinician may report a caregiver’s rating of 0.
  • the clinician will record the caregiver’s rating of 0 on the case report form (CRF) for a first visit.
  • CRF case report form
  • the clinician will consider the patient candidate’s response, the patient’ rating, the spouse’s response and the caregiver’s rating.
  • the clinician may record a clinician’s rating of 1 on the case report form (CRF) for a first visit for this patient candidate.
  • CRF case report form
  • the clinician will visit the clinician for a second interview, in which the clinician will ask the patient a series of questions.
  • the clinician may ask the patient candidate, for example, that“Since your last visit, do you feel that life is not worth living?”“Since your last visit, do you think about killing yourself?”“Since your last visit, have you tried to hurt (or kill) yourself?” “Since your last visit, how do you see the future?”
  • the clinician will give a patient’s rating about his thoughts on self-harm and suicide on a scale of 0-4 on a Global Clinician Assessment of Suicidality (GCAS):
  • the clinician may report a patient’s rating of 3.
  • the clinician will record the patient’s rating of 3 on a case report form (CRF) for a second visit.
  • CRF case report form
  • the clinician may ask the patient’s spouse appropriate questions, such as“Since your last visit, does your husband feel that life is not worth living?”“Since your last visit, does your husband think about killing himself?”“Since your last visit, has your husband tried to hurt (or kill) himself?”“Since your last visit, how does your husband see the future?”
  • the clinician will give a caregiver’s rating based on the spouse’s response about the husband’s thoughts on self- harm and suicide on a scale of 0-4 since the previous visit:
  • the clinician may report a caregiver’s of 2.
  • the clinician will record the caregiver’s rating of 2 on the case report form (CRF) for a second visit.
  • CRF case report form
  • the clinician will consider the patient candidate’s response, the patient’s rating, the spouse’s response and the caregiver’s rating.
  • the clinician may record a clinician’s rating of 3 on the case report form (CRF) for a second visit for this patient.
  • CRF case report form

Abstract

Provided herein are methods for assessing a patient's suicidality. Also provided herein are methods for including or excluding a patient from a clinical study group.

Description

METHODS FOR ASSESSING SUICIDALITY
CROSS REFERENCE
[0001] This application claims the benefit of priority of U.S. Provisional Patent Application No. 62/642,575, filed March 13, 2018, the content of which is incorporated herein by reference in its entirety.
FIELD
[0002] Provided herein are methods for assessing a patient’s suicidality. Also provided herein are methods for including or excluding a patient from a clinical study group.
BACKGROUND
[0003] Suicide or self-destructive behavior occurs in the context of different disease states, including both psychiatric and medical. According to the United States Centers for Disease Control and Prevent, in 2015, suicide was the lOth leading cause of death in the United States, with more than 44,000 deaths.
[0004] In recent years, there has been a great deal of attention paid to treatment-emergent suicidal ideation and behavior in clinical trials. The attention has resulted in part from retrospective findings of apparent treatment-emergent suicidal ideation and behavior caused by several different types of drugs, such as in the placebo-controlled anti-depressant trials in both pediatric (Hammad et al. Arch. Gen. Psychiatry, 2006, 63, 332-339) and adult (Stone et al. BMJ, 2009, b2880).
[0005] As evident in e.g. Kiosses et al., Curr. Psychiatry Rep. 2014 Nov; 16(11): 495, suicide in older adults is a major public concern, as the suicide rates in this population are alarmingly high. According to the Center for Disease Control, the suicide rates in all ages in the United States have steadily increased from 2000-2011, reaching 12.7/100,000 in 2011. Among different age groups, the suicide deaths of adults aged 50-74 years old almost doubled from 2000 to 2011, while the highest risk group for suicide is still older white males 85 years or older (Suicide rate in 2011 : 47.3/100,000). Additionally population studies have linked poor cognitive abilities to suicidal behavior. There may be a certain phase of cognitive decline or a particular cognitive profile that predisposes one to suicidal behavior. It is likely that age-related neurodegenerative and vascular changes modify older adults’ vulnerability to suicide. [0006] Thus, methods of prospectively assessing suicidal ideation and behavior in clinical trials of elderly patients, particularly patients with dementia, are important to ensure that patients who are already experiencing suicidal ideation and behavior are properly recognized before such patients are enrolled in the clinical trials, as well as identified during clinical trials and administered appropriate treatment.
[0007] There are currently no objective tools to assess and track suicidal risk in patients with dementia. Traditional suicidal risk assessment instruments for clinical trials, such as the
Columbia-Suicide Severity Rating Scale (C-SSRS) (commonly used in clinical trials), are validated in adults who do not have dementia, but not in patients with dementia. The C-SSRS is a complex instrument, requiring patients to have adequate memory and insight to answer the questions and as such not suitable for patients with dementia.
[0008] There exists a need to develop a succinct and more understandable suicidal risk assessment tool for assessing suicidal ideation and behavior, for example in patients with hallucinations and delusions associated with dementia-related psychosis.
SUMMARY
[0009] In one aspect, provided herein are methods for assessing a patient’s suicidality.
[0010] In one embodiment, the methods for assessing a patient’s suicidality comprise:
(a) asking a patient a series of questions on his or her thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide; (c) asking a caregiver a series of questions about the patient’s thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(d) recording a caregiver’s rating using the GCAS scale based on the patient’s response to the series of questions on the patient’s thoughts; and
(e) recording a clinician’s rating of the patient using the GCAS scale, wherein the patient’s rating, the caregiver’s rating and the patient’s response to the series of questions are considered by the clinician to determine the clinician’s rating of the patient;
wherein the clinician’s rating of the patient using the GCAS scale indicates the patient’s suicidality.
[0011] In certain embodiments, steps (a)-(e) are performed on a first interview.
[0012] In certain embodiments, the methods further comprise on a second interview:
(a) asking a patient a series of questions on his or her thoughts on self-harm since the patient is asked the series of questions during the first interview;
(b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide;
(c) asking a caregiver a series of questions about the patient's thoughts on self-harm and suicide since the patient is asked the series of questions during the first interview;
(d) recording a caregiver’s rating using the GCAS scale based on the patient’s response to the series of questions on the patient’s thoughts; and (e) recording a clinician’s rating of the patient using the GCAS scale, wherein the patient’s rating, the caregiver’s rating and the patient’s response to the series of questions are considered by the clinician to determine the clinician’s rating of the patient;
wherein the clinician’s rating of the patient using the GCAS scale indicates the patient’s suicidality.
[0013] In certain embodiments, the methods further comprise:
(f) communicating that the patient has been assessed to have an increased suicidality to a health care professional if the clinician’s rating using the GCAS scale is 3 or greater, or administered appropriate treatment.
[0014] In another aspect, provided herein are methods for including or excluding a patient from entering a clinical study group, or from continuing a clinical study.
[0015] In certain embodiments, the methods for including or excluding a patient from a clinical study group comprise:
(a) asking a patient a series of questions on his or her thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide;
(c) asking a caregiver a series of questions about the patient's thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions; (d) recording a caregiver’s rating using the GCAS scale based on the patient’s response to the series of questions on the patient’s thoughts;
(e) recording a clinician’s rating of the patient using the GCAS scale, wherein the patient’s rating, the caregiver’s rating and the patient’s response to the series of questions are considered by the clinician to determine the clinician’s rating of the patient; and
(f) identifying a clinical study group including the patient wherein the clinician’s rating of the patient is 2 or less on the GCAS scale or excluding the patient wherein the clinician’s rating of the patient is 3 or greater on the GCAS scale.
[0016] In certain embodiments of the methods provided herein, the patient is a patient having dementia.
[0017] In certain embodiments provided herein, the patient is a patient having Alzheimer’s dementia, Parkinson’s disease dementia, Lewy Body dementia, frontotemporal dementia, and vascular dementia, or any combination thereof.
[0018] In certain embodiments, the patient is a patient having or at risk of having dementia- related psychosis.
[0019] In certain embodiments, the patient is a patient having or at risk of having psychosis associated with a neurodegenerative disease or disorder.
[0020] In certain embodiments, the patient is a patient having or at risk of having
Alzheimer’s dementia.
[0021] In certain embodiments, the patient is a patient having or at risk of having
Parkinson’s disease.
[0022] In certain embodiments, the patient is a patient having or at risk of having agitation and aggression in Alzheimer’s dementia.
[0023] In another aspect, provided herein is a scale for assessing a patient’s suicidality said scale to conduct a clinical assessment of the patient’s suicidality according to a Global Clinician Assessment of Suicidality (GCAS) scale.
[0024] In certain embodiments, instructions of the scale comprise:
(a) asking a patient a series of questions on his or her thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions; (b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide;
(c) asking a caregiver a series of questions about the patient’s thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions, and recording the caregiver’s rating of the patient on a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on the patient’s thoughts;
instructions for a clinician how to assess the recordings; and
instructions for a clinical make a clinician’s rating of the patient.
[0025] In certain embodiments, the instructions further comprise recommended actions in view a clinician’s rating of 3 or greater on the GCAS scale, said rating of 3 or greater indicates an increased suicidality in the patient.
DETAILED DESCRIPTION
[0026] Provided herein are methods for assessing a patient’s suicidality.
[0027] In certain embodiments, the methods comprise:
(a) asking a patient a series of questions on his or her thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide;
(c) asking a caregiver a series of questions about the patient’s thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(d) recording a caregiver’s rating using the GCAS scale based on the patient’s response to the series of questions on the patient’s thoughts; and
(e) recording a clinician’s rating of the patient using the GCAS scale, wherein the patient’s rating, the caregiver’s rating and the patient’s response to the series of questions are considered by the clinician to determine the clinician’s rating of the patient;
wherein the clinician’s rating of the patient using the GCAS scale indicates the patient’s suicidality.
[0028] In certain embodiments, the steps (a)-(e) are performed on a first interview.
[0029] In certain embodiments, the patient is a patient having dementia.
[0030] In certain embodiments provided herein, the patient is a patient having Alzheimer’s dementia, Parkinson’s disease dementia, Lewy Body dementia, frontotemporal dementia, and vascular dementia, or any combination thereof.
[0031] A patient having dementia is a patient having impairment of one or more of the core mental function such as memory, communication and language, ability to focus and pay attention, reasoning and judgment, and visual perception. In certain embodiments a patient having dementia is a patient significantly impaired in at least two of the core mental functions, i.e. memory, communication and language, ability to focus and pay attention, reasoning and judgment, and visual perception.
[0032] In the assessment of suicidality of patients with dementia, it is important to gather information from other reliable sources besides the patient, as patients may not understand the questions, remember events over the previous days to weeks, have difficulty expressing their thoughts, or have insufficient insight to answer suicidal questions appropriately. Other reliable sources include the patient’s caregiver and clinician. In some aspects the caregiver’s answers ensure reliable answers.
[0033] In certain aspects disclosed herein relate to Global Clinician Assessment of
Suicidality (GCAS) providing a scale of assessing a patient’s suicidality, for example in a patient having dementia. GCAS provides a tool for assessing the patient’s suicidality, such as a tool to assessing the severity of suicidal symptoms, such as suicidal ideation and/or suicide attempts.
[0034] In certain aspects GCAS may be used as a threshold, e.g. to assess if a patient should be included of excluded from a clinical study group.
[0035] In certain aspects GCAS may be used to assess a patient’s suicidality over time, i.e. rating if a patient is getting more or less suicidal.
[0036] In certain embodiments, the above method further comprising on a second interview:
(a) asking a patient a series of questions on his or her thoughts on self-harm since the patient is asked the series of questions during the first interview;
(b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide;
(c) asking a caregiver a series of questions about the patient’s thoughts on self-harm and suicide since the patient is asked the series of questions during the first interview,
(d) recording a caregiver’s rating using the GCAS scale based on the patient’s response to the series of questions on the patients thoughts; and
(e) recording a clinician’s rating of the patient using the GCAS scale, wherein the patient’s rating, the caregiver’s rating and the patient’s response to the series of questions are considered by the clinician to determine the clinician’s rating of the patient;
wherein the clinician’s rating of the patient using the GCAS scale indicates the patient’s suicidality.
[0037] In certain embodiments, the clinician’s rating of 3 or greater on the GCAS scale indicates an increased suicidality in the patient. In some embodiments, the clinician’s rating of 4 on the GCAS scale indicates an increased suicidality. Additionally, a clinician’s rating increasing from e.g. 0 to 2 over a period of time also implies an increased suicidal ideation or suicidal action, or increased suicidality and may warrant further evaluation of the patient.
[0038] In certain embodiments, a clinician’s rating changing over time, i.e. from 0 to 2 over 3 months may be an indication of increased suicidality.
[0039] In certain embodiments, the methods further comprise: (f) communicating that the patient has been assessed to have an increased suicidality to a health care professional if the clinician’s rating using the GCAS scale is 3 or greater, optionally providing treatment of the suicidality.
[0040] In certain embodiments, the methods further comprise and alternative assessment, where a patient in a first rating obtained: (f) communicating that the patient has been assessed to have an increased suicidality to a health care professional if the clinician’s rating using the GCAS scale is 3 or greater, optionally providing treatment of the suicidality.
[0041] Also provided herein are methods for including or excluding a patient from a clinical study group.
[0042] In certain embodiments, the methods comprise:
(a) asking a patient a series of questions on his or her thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is 0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide;
(c) asking a caregiver a series of questions about the patient's thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(d) recording a caregiver’s rating using the GCAS scale based on the patient’s response to the series of questions on the patient’s thoughts;
(e) recording a clinician’s rating of the patient using the GCAS scale, wherein the patient’s rating, the caregiver’s rating and the patient’s response to the series of questions are considered by the clinician to determine the clinician’s rating of the patient; and
(f) identifying a clinical study group including the patient wherein the clinician’s rating of the patient is 2 or less on the GCAS scale or excluding the patient wherein the clinician’s rating of the patient is 3 or greater on the GCAS scale.
[0043] In certain embodiments, the patient is having dementia.
[0044] In certain embodiments, the patient is a human that has or is at risk for a disease, disorder or condition provided herein. In certain embodiments, the patient has or is at risk of having a disease, disorder or condition selected from the group of dementia, Alzheimer’s dementia, Parkinson’s disease, e.g. Dementia in Parkinson’s disease having dementia, depression, schizophrenia and psychosis. In certain embodiments, the patient has or is at risk of having dementia, such as Alzheimer’s dementia, Parkinson’s disease dementia, Lewy Body dementia, frontotemporal dementia, and vascular dementia, or any combination thereof. In certain embodiments, the patient has or is at risk of having a neurodegenerative disease. In certain embodiments, the patient has or is at risk of having dementia-related psychosis. In certain embodiments, the patient has or is at risk of having psychosis associated with a neurodegenerative disease. In certain embodiments, the patient has or is at risk of having Alzheimer’s dementia. In certain embodiments, the patient has or is at risk of having Parkinson’s disease. In certain embodiments, the patient has or is at risk of having agitation and aggression in Alzheimer’s dementia.
[0045] In certain embodiments, the patient is administered an agent for the treatment of psychosis associated with a neurodegenerative disease or disorder. In certain embodiments, the patient is administered an agent for the treatment of Parkinson’s disease psychosis. In certain embodiments, the patient is administered an agent for the treatment of Alzheimer’s disease psychosis. Exemplary agents used for the treatment of Alzheimer’s disease psychosis include, but are not limited to, memantine, cholinesterase inhibitors, tacrine, donepezil, and rivastigmine. In certain embodiments, the patient is administered pimavanserin.
[0046] In certain embodiments, the age of the patient is 45 years or older, 50 years or older, or 55 years or old, or 60 years or older, or 65 years or older, or 70 years or older at baseline. In another embodiment, the age of the patient is 50 years or older.
[0047] In an embodiment, the cognitive status of the patient is not impaired. In another embodiment, the cognitive status patient is determined by the Mini-Mental State Examiner (MMSE) score.
[0048] In certain embodiments, the patient is a candidate to be enrolled in a clinical trial study group. In certain embodiment, the patient is enrolled in a clinical trial study group.
[0049] In certain embodiments, the interview is performed in person. In certain
embodiments, the interview is performed in person, e.g. during a visit to the clinician responsible for the rating of patient. In one embodiment, the interview is performed using an exchange system capable of exchanging information between individuals. In another embodiment, the interview is performed by asking questions recorded on a tangible media and then by recording the patient’s response and/or the caregiver’s response on a tangible media. Such tangible media can include, for example, an audio tape or on a video tape. In certain embodiments, a clinician asks a patient questions using a video streaming interface or system.
[0050] In certain embodiments, the second interview is at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 weeks after the first interview. In certain embodiments, the second interview is 1 or 2 weeks after the first interview. In certain embodiments, the second interview is 2 weeks after the first interview.
[0051] In certain embodiments, multiple follow-up interviews are performed after the first interview. In certain embodiments, multiple follow-up interviews are performed at a fixed interval of time period. In one embodiment, multiple follow-up interviews are performed every 1, 2, 3, 4, 5, 6, 7, or 8 weeks after the first interview.
[0052] In certain embodiments, each item of the scale is scored as a whole number, not a fraction.
[0053] In certain embodiments, the clinician rates after interviewing the patient and caregiver.
[0054] In certain embodiments, the clinician’s rating is the primary rating of GCAS, and the score by which decisions are made about the patient’s suicidality.
[0055] In one embodiment, the patient’s rating is a rating assigned to the patient by the clinician asking questions to the patient in the interview. In another embodiment, the patient’s rating is a rating assigned to the patient by the patient’s caregiver. In yet another embodiment, the patient’s rating is a self-reported rating by the patient. In yet another embodiments, the patient’s rating is a rating assigned by an expert system. In certain embodiments, the patient’s rating is based on the patient’s response to the series of questions on his or her thoughts on self- harm and suicide.
[0056] In one embodiment, the caregiver’s rating is the rating assigned to the patient by the clinician asking questions to the caregiver in the interview. In one preferred embodiment, the caregiver’s rating is the rating assigned to the patient by the caregiver. In yet another embodiment, the caregiver’s rating is a rating assigned by an expert system. In certain embodiments, the caregiver’s rating is based on the patient’s response to the series of questions on the patient’s thoughts on self-harm and suicide.
[0057] In certain embodiments, each item of the scale is scored as a whole number, not a fraction, and the clinician rates after interviewing the patient and caregiver, and the clinician’s rating is the primary rating of GCAS, and the score by which decisions are made about the patient’s suicidality.
[0058] In certain embodiments, a clinician rating of 3 or greater on the GCAS scale indicates active suicidal ideation or suicidal action.
[0059] In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide are simple, direct and open-ended questions. In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide further comprise additional probing questions when appropriate. In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide comprise questions similar to those in other scales. In one embodiment, the series of questions on the patient’s thoughts on self-harm and suicide comprise questions similar to those used in the Clinical Global Impression (CGI) scale. In another embodiment, the series of questions on the patient’s thoughts on self-harm and suicide comprise questions similar to those used in the improved Clinical Global Impression (i-CGI) scale.
[0060] In certain embodiments, the additional probing questions comprise, for example, one or more following questions:
• Could you be more explicit about his?
• Could you come back to that?
• What is the main point in what you said just now?
• What do you mean by this phrase?
[0061] In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide comprise, for example, one or more of the following questions:
• Do you feel that life is not worth living?
• Do you wish you were dead?
• Do you ever want to sleep without waking up?
• Do you think about killing yourself?
• Have you tried to hurt (or kill) yourself?
[0062] In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide comprise, for example, one or more of the following questions:
• How do you see the future?
• Do you sometimes think of death?
• Can you say something else about yourself to help us to understand what you are thinking?
[0063] In certain embodiments, at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 questions are asked as the series of questions on the patient’s thoughts on self-harm and suicide.
[0064] In certain embodiments, the caregiver is asked a similar series of questions about the patient’s thoughts on self-harm and suicide to those asked to the patient. [0065] In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide during the first interview is about the patient’s thoughts on self-harm and suicide over the 3 months prior to the first interview. In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide during the first interview is about the patient’s thoughts on self-harm and suicide over the lifetime prior to the first interview. In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide during the first interview is about the patient’s thoughts on self-harm and suicide over the 3 months prior to the first interview and over the lifetime prior to the first interview.
[0066] In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide during the second interview is about the patient’s thoughts on self-harm and suicide since the first interview. In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide during the second interview is about the patient’s thoughts on self-harm and suicide during a period of time between the first interview and the second interview. In certain embodiments, the series of questions on the patient’s thoughts on self-harm and suicide during the second interview is about the patient’s current thoughts on self-harm and suicide during the second interview.
[0067] In certain embodiments, the patient and the caregiver are both interviewed in the interview.
[0068] In certain embodiments, the patient’s rating using the GCAS scale and the caregiver’s rating of the patient using the GCAS scale are recorded prior to determination of the clinician’s rating of the patient using the GCAS scale. In certain embodiments, the determination of clinician’s rating of the patient using the GCAS scale takes into account all available information including the patient’s response and the caregiver’s response to the series of questions on the patient’s thoughts on self-harm and suicide. In certain embodiments, In certain embodiments, the determination of clinician’s rating of the patient using the GCAS scale takes into account adverse event reporting.
[0069] In certain preferred embodiments, the clinician’s rating on the second interview is independent of the clinician’s rating on the first visit. In certain embodiments, the clinician’s rating on the second interview takes into account of the information of the first interview including, for example, the patient’s response, the caregiver’s response, and/or the clinician’s rating during the first interview. [0070] In certain embodiments, a primary assessment is recorded in a case report form (CRF). In certain embodiments, the clinician’s rating is the primary assessment. In one embodiment, the patient’s rating, the caregiver’s rating and the clinician’s rating are recorded in the CRF. In another embodiment, only the clinician’s rating is recorded in the CRF.
[0071] In another aspect, provided herein is a scale for assessing a patient’s suicidality said scale to conduct a clinical assessment of the patient’s suicidality according to a Global Clinician Assessment of Suicidality (GCAS) scale.
[0072] In certain embodiments, instructions of the scale comprise:
(a) asking a patient a series of questions on his or her thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide;
(c) asking a caregiver a series of questions about the patient’s thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions, and recording the caregiver’s reported rating on a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts;
instructions for a clinician how to assess the recordings; and
instructions for a clinical make a clinician’s rating of the patient. [0073] In certain embodiments, the instructions further comprise recommended actions in view a clinician’s rating of 3 or greater on the GCAS scale, said rating of 3 or greater indicates an increased suicidality in the patient.
Definitions
[0074] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art. In the event that there is a plurality of definitions for a term herein, those in this section prevail unless stated otherwise.
[0075] The term“patient” refers to a human. In one embodiment, the patient has or is at risk for a disease, disorder or condition provided herein. In another embodiment, the patient has or is at risk for a disease, disorder or condition wherein the disease, disorder or condition, or a symptom thereof, can be treated, prevented or ameliorated by the administration of
pimavanserin. In another embodiment, the patient has a disease, disorder or condition wherein the disease, disorder or condition, or a symptom thereof, can be treated, prevented or ameliorated by the administration of pimavanserin tartrate salt.
[0076] As used herein, the term“ask” or“asking” refer to ask one or more questions to elicit a response in personal or through an exchange system capable of exchanging information between individuals. In certain embodiments, a clinician asks a patient questions in person during the patient’s visit to the clinician. In certain embodiments, a clinician asks a patient questions recorded on a tangible media, for example, questions recorded on an audio tape or on a video tape. In certain embodiments, a clinician asks a patient questions using a video streaming interface.
[0077] The term“a series of questions on his or her thoughts on self-harm and suicide” refers to questions that include questions about a human’s thoughts about a wish to be dead or not alive, or wish to fall asleep and not wake-up; about nonspecific thoughts of wanting end his or her life or commit suicide (e.g.,“I’ve thought about killing myself) without general thought of ways to kill oneself/associated methods, intent, or plan; about thought of at least one method of suicide; about active suicidal thoughts of killing oneself and about intent to act on such thought; and about thoughts of killing oneself with details of plan fully or partially worked out and about some intent to carry it out. In certain embodiments, the questions are similar to questions used in the Clinical Global Impressions (CGI) scale.
[0078] The term“lifetime” refers to the duration of the existence of a human. [0079] As used herein, the terms“record” or“recording” refer to describe the documentary results of an examination or interview and storage of such documentary results on a tangible medium. In certain embodiments, information can be recorded on a paper or any electronic media including, among other things, word processor documents, web browser pages, pictures, tables, charts, video clips, audio clips, multi-media presentations, etc.
[0080] As used herein, the term“clinician” refers to an individual who has knowledge of assessment and reporting of suicidality, with an appropriate clinical background for making a clinical judgment. In certain embodiments, the clinician is a licensed professional, for example, a physician, psychologist, social worker, behavior therapist, nurse practitioner, or psychiatric nurse. In certain embodiments, the clinician is an investigator in a clinical study.
[0081] As used herein, the term“caregiver” refers to the act of providing assistance and support to a human who has physical, psychological, or developmental needs. In certain embodiments, a caregiver is a person who provides assistance and support to family members or acquaintances who has physical, psychological, or developmental needs. In certain
embodiments, a caregiver is a paid member of a person's social network who helps him or her with activities of daily living. Caring for others generally takes on three forms: instrumental, emotional, and informational caring. Instrumental help includes activities such as shopping for someone who is disabled or cleaning for an elderly parent. Caregiving also involves a great deal of emotional support, which may include listening, counseling, and companionship. Finally, part of caring for others may be informational in nature, such as learning how to alter the living environment of someone in the first stages of dementia. Typical duties of a caregiver might include taking care of someone who has a chronic illness or disease; managing medications or talking to doctors and nurses on someone's behalf; helping to bathe or dress someone who is frail or disabled; or taking care of household chores, meals, or bills for someone who cannot do these things alone.
[0082] As used herein, the term“patient’s suicidality” refers to the evaluation of a patient’s likelihood of suicide including suicidal ideation and behavior, which is reflected or measured using a Global Clinician Assessment of Suicidality (GCAS) scale. The GCAS scale rates a patient’s suicidality on a 0-4 scale, where a rating of 0 represents absence of suicidal ideation or behavior; a rating of 1 represents that the patients feels life is not worth living; a rating of 2 represents that the patient wishes he/she were dead or any thoughts of possible death to self; a rating of 3 represents that the patient has suicidal ideas or gesture; and a rating of 4 represents the patient attempts at suicide.
[0083] “Neurodegenerative disease or disorder” refers to a disease or disorder selected from the group consisting of Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, frontotemporal lobar degeneration associated with protein TDP-43 (FTLD-TDP), dementia with lewy bodies (DLB), vascular dementia, amyotrophic lateral sclerosis (ALS), and other neurodegenerative related dementias due to changes in the brain caused by ageing, disease or trauma; or spinal cord injury.
[0084] “Expert system” refers to a computer program executing on a computer that implements abductive reasoning or logic configured to determine a rating based on information input. The determination may be based on specific criteria set beforehand and driven by events. For instance, the computer program may be configured to determine a rating score of a patient based on the response information the patient provide and also based on the specific criteria set by a clinician.
EXAMPLES
EXAMPLE 1:
[0085] Selected patient candidates may be home-cared by his or her spouse, which in this case the caregiver will be the patient candidate’s spouse. In the prophetic example below, the patient candidate is the husband and his spouse is the caregiver.
[0086] A patient candidate and his spouse will be requested to visit a clinician for a first interview (day 1), in which the clinician will ask the patient candidate a series of questions such as those exemplified herein. During the first part of the interview, the clinician will ask the patient candidate, for example, that“In your lifetime and in the past three months, do you feel that life is not worth living?”“In your lifetime and in the past three months, do you think about killing yourself?”“In your lifetime and in the past three months, have you tried to hurt (or kill) yourself?”“In your lifetime and in the past three months, how do you see the future?” Following the patient candidate’s response to the questions, the clinician will give a patient’s rating based on the patient’s response about his or her thoughts on self-harm and suicide on a scale of 0-4 on a Global Clinician Assessment of Suicidality (GCAS):
0 = Absent
1 = Feels life is not worth living 2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide.
For the purposes of this example, the clinician may report a patient’s rating of 1. The clinician will record the patient’s rating of 1 on a case report form (CRF) for a first visit.
[0087] During the second part of the interview on day 1, the clinician may ask the patient candidate’s spouse appropriate questions such as“In your husband’s lifetime and in the past three months, does your husband feel that life is not worth living?”“In your husband’s lifetime and in the past three months, does your husband think about killing himself?”“In your husband’s lifetime and in the past three months, has your husband tried to hurt (or kill) himself?”“In your husband’s lifetime and in the past three months, how does your husband see the future?”
Following the spouse’s response to the questions, the clinician will give a caregiver’s rating based on the spouse’s response about the husband’s thoughts on self-harm and suicide on a scale of 0-4 on a Global Clinician Assessment of Suicidality (GCAS):
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide.
For the purposes of this example, the clinician may report a caregiver’s rating of 0. The clinician will record the caregiver’s rating of 0 on the case report form (CRF) for a first visit.
[0088] The clinician will consider the patient candidate’s response, the patient’ rating, the spouse’s response and the caregiver’s rating. For purposes of this example, the clinician may record a clinician’s rating of 1 on the case report form (CRF) for a first visit for this patient candidate. In this case, the patient candidate will not be excluded from a clinical study group of a clinical trial.
[0089] On day 21, the patient in the clinical study group and his spouse will visit the clinician for a second interview, in which the clinician will ask the patient a series of questions. During the first part of the interview, the clinician may ask the patient candidate, for example, that“Since your last visit, do you feel that life is not worth living?”“Since your last visit, do you think about killing yourself?”“Since your last visit, have you tried to hurt (or kill) yourself?” “Since your last visit, how do you see the future?” Following the patient’s response to the questions, the clinician will give a patient’s rating about his thoughts on self-harm and suicide on a scale of 0-4 on a Global Clinician Assessment of Suicidality (GCAS):
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide.
For the purposes of this example, the clinician may report a patient’s rating of 3. The clinician will record the patient’s rating of 3 on a case report form (CRF) for a second visit.
[0090] During the second part of the interview on day 21, the clinician may ask the patient’s spouse appropriate questions, such as“Since your last visit, does your husband feel that life is not worth living?”“Since your last visit, does your husband think about killing himself?”“Since your last visit, has your husband tried to hurt (or kill) himself?”“Since your last visit, how does your husband see the future?” Following the spouse’s response to the questions, the clinician will give a caregiver’s rating based on the spouse’s response about the husband’s thoughts on self- harm and suicide on a scale of 0-4 since the previous visit:
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide.
For the purposes of this example, the clinician may report a caregiver’s of 2. The clinician will record the caregiver’s rating of 2 on the case report form (CRF) for a second visit.
[0091] The clinician will consider the patient candidate’s response, the patient’s rating, the spouse’s response and the caregiver’s rating. For the purposes of this example, the clinician may record a clinician’s rating of 3 on the case report form (CRF) for a second visit for this patient.
[0092] The clinician will report to an investigator of the clinical trial. The patient will be excluded in the clinical study group of the clinical trial, and will stop receiving the drug or placebo that will be administered in the clinical trial. [0093] The examples set forth above are provided to give those of ordinary skill in the art with a complete disclosure and description of how to make and use the claimed embodiments, and are not intended to limit the scope of what is disclosed herein. Modifications that are obvious to persons of skill in the art are intended to be within the scope of the following claims. All publications, patents, and patent applications cited in this specification are incorporated herein by reference as if each such publication, patent or patent application were specifically and individually indicated to be incorporated herein by reference.

Claims

WHAT IS CLAIMED IS:
1. A method for assessing a patient’s suicidality comprising:
(a) asking a patient a series of questions on his or her thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide;
(c) asking a caregiver a series of questions about the patient’s thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(d) recording a caregiver’s rating using the GCAS scale based on the caregiver’s response to the series of questions on the patient’s thoughts; and
(e) recording a clinician’s rating of the patient using the GCAS scale, wherein the patient’s rating, the caregiver’s rating and the patient’s response to the series of questions are considered by the clinician to determine the clinician’s rating of the patient;
wherein the clinician’s rating of the patient using the GCAS scale indicates the patient’s suicidality.
2. The method of claim 1, wherein steps (a)-(e) are performed on a first interview.
3. The method of claim 2, further comprising on a second interview:
(a) asking a patient a series of questions on his or her thoughts on self-harm since the patient is asked the series of questions during the first interview;
(b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide;
(c) asking a caregiver a series of questions about the patient's thoughts on self-harm and suicide since the patient is asked the series of questions during the first interview;
(d) recording a caregiver’s rating of the patient using the GCAS scale; and
(e) recording a clinician’s rating using the GCAS scale based on the patient’s response to the series of questions on the patient’s thoughts, wherein the patient’s rating, the caregiver’s rating and the patient’s response to the series of questions are considered by the clinician to determine the clinician’s rating of the patient;
wherein the clinician’s rating of the patient using the GCAS scale indicates the patient’s suicidality.
4. The method of any one of claims 1-3, further comprising
(f) communicating that the patient has been assessed to have an increased suicidality to a health care professional if the clinician’s rating using the GCAS scale is 3 or greater, or communicating that the patient has been assessed to have an increased suicidality to a health care professional if the clinician’s rating using the GCAS scale has changed by
2 units over a period of time, or
administering treatment of the increase suicidality.
5. A method for including or excluding a patient from a clinical study group comprising:
(a) asking a patient a series of questions on his or her thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self
3 = Suicidal ideas or gesture
4 = Attempt at suicide;
(c) asking a caregiver a series of questions about the patient's thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(d) recording a caregiver’s rating using the GCAS scale based on the patient’s response to the series of questions on the patient’s thoughts;
(e) recording a clinician’s rating of the patient using the GCAS scale, wherein the patient’s rating, the caregiver’s rating and the patient’s response to the series of questions are considered by the clinician to determine the clinician’s rating of the patient; and
(f) identifying a clinical study group including the patient wherein the clinician’s rating of the patient is 2 or less on the GCAS scale or excluding the patient wherein the clinician’s rating of the patient is 3 or greater on the GCAS scale.
6. The method of any one of claims 1-5, wherein the patient is a patient having dementia.
7. The method of any one of claims 1-5, wherein the patient is a patient having or at risk of having dementia-related to a neurodegenerative disease.
8. The method of any one of claims 1-5, wherein the patient is a patient having or at risk of having Alzheimer’s dementia, Parkinson’s disease dementia, Lewy Body dementia, frontotemporal dementia, and vascular dementia, or any combination thereof.
9. The method of claim 8, wherein the patient is a patient having or at risk of having Alzheimer’s dementia.
10. The method of any one of claims 1-5, wherein the patient is a patient having or at risk of having Parkinson’s disease.
11. The method of any one of claims 1-5, wherein the patient is a patient having or at risk of having agitation and aggression in Alzheimer’s dementia.
12. A scale for assessing a patient’s suicidality said scale to conduct a clinical assessment of the patient’s suicidality according to a Global Clinician Assessment of Suicidality (GCAS) scale, wherein instructions of the scale comprise:
(a) asking a patient a series of questions on his or her thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions;
(b) recording the patient’s rating using a Global Clinician Assessment of Suicidality (GCAS) scale based on the patient’s response to the series of questions on his or her thoughts for the period over the patient’s lifetime and recording the patient’s rating using the GCAS scale based on the patient’s response to the series of questions on his or her thoughts for the 3 months prior to when the patient is asked the series of questions, wherein the rating using the GCAS is
0 = Absent
1 = Feels life is not worth living
2 = Wishes he/she were dead or any thoughts of possible death to self 3 = Suicidal ideas or gesture
4 = Attempt at suicide;
(c) asking a caregiver a series of questions about the patient’s thoughts on self-harm and suicide over patient’s lifetime and over the 3 months prior to when the patient is asked the series of questions, and recording the caregiver’s rating on a GCAS scale based on the patient’s response to the series of questions on the patient’s thoughts; instructions for a clinician how to assess the recordings; and
instructions for a clinical how to make a clinician’s rating of the patient.
13. The method of any one of claims 1-12, wherein the patient’s rating is a self-reported rating by the patient, or a rating assigned to the patient by the clinician asking questions to the patient in the interview, or a rating assigned to the patient by the patient’s caregiver, or a rating assigned by an expert system.
14. The method of any one of claims 1-13, wherein the caregiver’s rating is a rating assigned to the patient by the patient’s caregiver, or a rating assigned to the patient by the clinician asking questions to the patient, or a rating assigned by an expert system.
15. The scale for assessing a patient’s suicidality according to claim 12, wherein the instructions further comprise recommended actions in view a clinician’s rating of 3 or greater on the GCAS scale, said rating of 3 or greater indicates an increased suicidality in the patient.
PCT/US2019/021618 2018-03-13 2019-03-11 Methods for assessing suicidality WO2019177973A1 (en)

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US11191757B2 (en) 2016-03-25 2021-12-07 Acadia Pharmaceuticals Inc. Combination of pimavanserin and cytochrome P450 modulators
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US11135211B2 (en) 2017-04-28 2021-10-05 Acadia Pharmaceuticals Inc. Pimavanserin for treating impulse control disorder
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