JP6196041B2 - 大うつ病を有する患者において減量療法を提供する方法 - Google Patents
大うつ病を有する患者において減量療法を提供する方法 Download PDFInfo
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
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- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/439—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom the ring forming part of a bridged ring system, e.g. quinuclidine
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- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
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Description
薬学的に許容されるその塩の量は、1日あたり約5mgから約50mgである。特定の実施形態において、ブプロピオンまたは薬学的に許容されるその塩の量は、1日あたり約30mgから約500mgである。特定の実施形態において、ナルトレキソンまたは薬学的に許容されるその塩の量は、1日あたり約5mgから約50mgであり、ブプロピオンまたは薬学的に許容されるその塩の量は、1日あたり約30mgから約500mgである。特定の実施形態において、ナルトレキソンまたは薬学的に許容されるその塩の量は、1日あたり約4mgから約50mgであり、ブプロピオンまたは薬学的に許容されるその塩の量は、1日あたり約30mgから約500mgである。特定の実施形態において、ナルトレキソンまたは薬学的に許容されるその塩の量は、1日あたり約16mgまたは約32mgであり、ブプロピオンまたは薬学的に許容されるその塩の量は、1日あたり約360mgである。特定の実施形態において、患者に投与される初期日用量は、約4mgまたは約8mgのナルトレキソンまたは薬学的に許容されるその塩と約90mgのブプロピオンまたは薬学的に許容されるその塩とであり、患者に維持のために投与される日用量は、約16mgまたは約32mgのナルトレキソンまたは薬学的に許容されるその塩と約360mgのブプロピオンまたは薬学的に許容されるその塩とである。特定の実施形態において、ナルトレキソンまたは薬学的に許容されるその塩の日用量は、1週目4mgから2週目8mg、3週目12mg、4週目およびそれ以降16mgならびに1週目8mgから2週目16mg、3週目24mg、4週目およびそれ以降32mgからなる群から選択される投与スケジュールであって、かつブプロピオンまたは薬学的に許容されるその塩の日用量は、1週目90mgから2週目180mg、3週目270mg、4週目およびそれ以降360mgまで漸増される。特定の実施形態において、ナルトレキソンまたは薬学的に許容されるその塩の量は、1日あたり約32mgであり、ブプロピオンまたは薬学的に許容されるその塩の量は、1日あたり約360mgである。特定の実施形態において、方法は、ナルトレキソンもしくは薬学的に許容されるその塩、ブプロピオンもしくは薬学的に許容されるその塩、または双方の投与量を、患者の大うつ病性障害を治療するために必要に応じて調整することをさらに含む。特定の実施形態において、方法は、ナルトレキソンもしくは薬学的に許容されるその塩、ブプロピオンもしくは薬学的に許容されるその塩、または双方の投与量を、患者の過体重または肥満を治療するために必要に応じて調整することをさらに含む。特定の実施形態において、ナルトレキソンまたは薬学的に許容されるその塩とブプロピオンまたは薬学的に許容されるその塩のうちの少なくとも一方は持続放出製剤である。特定の実施形態において、ナルトレキソンまたは薬学的に許容されるその塩とブプロピオンまたは薬学的に許容されるその塩のそれぞれは持続放出製剤である。特定の実施形態において、方法は、ナルトレキソンまたは薬学的に許容されるその塩とブプロピオンまたは薬学的に許容されるその塩とを食品と共に投与することをさらに含む。
以下の実施例は、非限定的なものであり、本発明の多様な態様の代表例にすぎない。
ナルトレキソンおよびブプロピオン
BMI≧27kg/m2かつBMI≦43kg/m2の被験者における、うつ病および体重増加の最小化についての、持続放出性ナルトレキソン(ナルトレキソンSR)+持続放出性ブプロピオン(ブプロピオンSR)の24週間のオープンラベル試験を、Table 1(表1)に示す用量漸増スケジュールに従って行った。すべての被験者が、(精神異常の特徴はなく)大うつ病のDSM-IV判定基準を満たしており、かつIDS-SR総スコア≧26を有していた。
ナルトレキソンおよびブプロピオン
25よりも高いBMIを有する患者を特定する。各患者は、ブプロピオン(SR)の90mgの錠剤2個を1日2回に加えて、ナルトレキソン(SR)の8mgの錠剤2個を1日2回服用するように指示される。
ナルトレキソンおよびブプロピオン
多施設無作為盲検化プラセボ対照臨床試験において、以下の薬剤の組合せを試験する:
Claims (15)
- 大うつ病性障害に罹患している、過体重または肥満である患者に減量療法を提供するための使用のためのナルトレキソンまたは薬学的に許容されるその塩およびブプロピオンまたは薬学的に許容されるその塩の組み合わせを含む組成物であって、
ナルトレキソンまたは薬学的に許容されるその塩の量が1日あたり32mgであり、かつブプロピオンまたは薬学的に許容されるその塩の量が1日あたり360mgである、組成物。 - 患者においてうつ病の症状を軽減させるためのさらなる使用のための、請求項1に記載の組成物。
- 患者が双極性障害に罹患していない、請求項1に記載の組成物。
- 減量を誘導する組合せが、1日あたり少なくとも1回投与される、請求項1に記載の組成物。
- ナルトレキソンまたは薬学的に許容されるその塩が、ブプロピオンまたは薬学的に許容されるその塩の前または後に投与される、請求項1に記載の組成物。
- ナルトレキソンまたは薬学的に許容されるその塩とブプロピオンまたは薬学的に許容されるその塩とが、単一の経口剤形中にある、請求項1に記載の組成物。
- 単一の経口剤形が、薬学的に許容される添加剤、賦形剤、または担体をさらに含有する、請求項6に記載の組成物。
- 大うつ病性障害に罹患している、過体重または肥満である患者に減量療法を提供するための使用のためのナルトレキソンまたは薬学的に許容されるその塩およびブプロピオンまたは薬学的に許容されるその塩の組み合わせを含む組成物であって、
患者に投与される初期日用量が、ナルトレキソンまたは薬学的に許容されるその塩8mgとブプロピオンまたは薬学的に許容されるその塩90mgとであり、患者に維持のために投与される日用量が、ナルトレキソンまたは薬学的に許容されるその塩32mgとブプロピオンまたは薬学的に許容されるその塩360mgとである、組成物。 - 大うつ病性障害に罹患している、過体重または肥満である患者に減量療法を提供するための使用のためのナルトレキソンまたは薬学的に許容されるその塩およびブプロピオンまたは薬学的に許容されるその塩の組み合わせを含む組成物であって、
ナルトレキソンまたは薬学的に許容されるその塩の日用量が、1週目8mgから2週目16mg、3週目24mg、4週目およびそれ以降32mgまで漸増され、かつブプロピオンまたは薬学的に許容されるその塩の日用量が、1週目90mgから2週目180mg、3週目270mg、4週目およびそれ以降360mgまで漸増される、組成物。 - ナルトレキソンまたは薬学的に許容されるその塩とブプロピオンまたは薬学的に許容されるその塩のうちの少なくとも一方が持続放出製剤である、請求項1に記載の組成物。
- ナルトレキソンまたは薬学的に許容されるその塩とブプロピオンまたは薬学的に許容されるその塩の両者が持続放出製剤である、請求項1に記載の組成物。
- ナルトレキソンまたは薬学的に許容されるその塩とブプロピオンまたは薬学的に許容されるその塩の両者が持続放出製剤である、請求項9に記載の組成物。
- ナルトレキソンまたは薬学的に許容されるその塩とブプロピオンまたは薬学的に許容されるその塩が単一経口剤形である、請求項12に記載の組成物。
- 少なくとも12週間投与される、請求項1に記載の組成物。
- 少なくとも24週間投与される、請求項1に記載の組成物。
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US29384410P | 2010-01-11 | 2010-01-11 | |
US61/293,844 | 2010-01-11 | ||
PCT/US2011/020712 WO2011085331A1 (en) | 2010-01-11 | 2011-01-10 | Methods of providing weight loss therapy in patients with major depression |
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JP2013516493A JP2013516493A (ja) | 2013-05-13 |
JP2013516493A5 JP2013516493A5 (ja) | 2014-02-27 |
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JP2016093140A Pending JP2016138142A (ja) | 2010-01-11 | 2016-05-06 | 大うつ病を有する患者において減量療法を提供する方法 |
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US (4) | US9248123B2 (ja) |
EP (2) | EP3659604A1 (ja) |
JP (2) | JP6196041B2 (ja) |
KR (2) | KR20120124423A (ja) |
CN (1) | CN102724878A (ja) |
AU (2) | AU2011203867B2 (ja) |
BR (1) | BR112012016783A2 (ja) |
CA (1) | CA2785822C (ja) |
ES (1) | ES2762113T3 (ja) |
IL (2) | IL220610A (ja) |
MX (1) | MX344303B (ja) |
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