一般的な不安障害におけるMM120 (ライサーギド) の単一治療:ランダム化臨床試験

Reid Robison¹, Robert Barrow², Craig Conant²

¹Cedar Clinical Research, Draper, Utah.

JAMA

|September 4, 2025

まとめ

一回投与したMM120は,中度から重度の汎用不安障害 (GAD) の成人の不安を有意に軽減しました. 高用量MM120は用量依存の効果を示し,GAD治療としての可能性を裏付けました.

科学分野:

精神科
薬理学について
臨床試験

背景:

一般的な不安障害 (GAD) は,効果的な治療を必要とする一般的な精神疾患です.
GADの現在の薬剤療法では,有効性と耐性を改善するために継続的な研究が必要である.

研究の目的:

適度から重度のGADを経験する成人のMM120 (リサージドDタルトラート) の投与量反応を調査する.
プラセボと比較して,複数の用量範囲で単回投与の有効性を評価する.

主な方法:

中度から重度のGADを持つ198人の成人を対象とした2b期,多センター,ランダム化,ダブルブラインド,プラセボ対照試験です.
参加者はMM120 (25,50,100,または200μg) またはプラセボの単回投与を受けた.
4週間のハミルトン不安評価スケール (HAM- A) の変化によって評価され,MCP- Mod法で分析された.

主要な成果:

プラセボと比較して100μgおよび200μgのMM120用量群では,第4週にHAM-Aスコアが統計的に有意に低下した.
25μgおよび50μgのMM120用量群は,プラセボと統計的に有意な違いを示さなかった.
視覚的知覚の変化,吐き気,頭痛を含む有害事象は,投与量に依存し,既知の効果と一致した.

結論:

MM120の単発投与は,中度から重度のGADの患者で,用量依存の不安症状の軽減を示した.
この結果はMM120の有効性を支持し,将来の第3相試験に最適な用量を選択するための重要なデータを提供します.

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