A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy among Depressed Outpatients with Inadequate Response to Prior Antidepressant Therapy (ADAPT-A Study)
A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy among Depressed Outpatients with Inadequate Response to Prior Antidepressant Therapy (ADAPT-A Study)
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DOI：
10.1159/000332050
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发表时间：
2012-01-01
影响因子：
22.8
通讯作者：
Pollack, Mark
中科院分区：
文献类型：
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作者：
Fava, Maurizio;Mischoulon, David;Pollack, Mark
背景：我们评估了在抗抑郁药物治疗(ADT)的基础上加用小剂量阿立哌唑对先前ADT反应不佳的重度抑郁障碍(MDD)患者的疗效。方法：采用序贯平行对照设计，225例MDD患者随机分为阿立哌唑2 mg/d和安慰剂两个30d阶段，药物/药物(第1阶段2 mg/d；第2阶段5 mg/d)、安慰剂/安慰剂(两阶段均为安慰剂)和安慰剂/药物(第1阶段为安慰剂；第2阶段为2 mg/d)的随机比为2：3：3。符合条件的受试者是MDD被独立认为是有效的、具有更安全标准的患者。受试者已经接受ADT=8周，并且对>；=1和
Background: We assessed the efficacy of low-dose aripiprazole added to antidepressant therapy (ADT) in major depressive disorder (MDD) patients with inadequate response to prior ADT. Methods: As per the sequential parallel comparison design, 225 MDD subjects were randomized to adjunctive treatment with aripiprazole 2 mg/day or placebo across two 30-day phases, with a 2:3:3 randomization ratio to drug/drug (aripiprazole 2 mg/day in phase 1; 5 mg/day in phase 2), placebo/placebo (placebo in both phases), and placebo/drug (placebo in phase 1; aripiprazole 2 mg/day in phase 2). Eligible subjects were patients whose MDD was independently deemed 'valid' with SAFER criteria. Subjects had been receiving ADT for >= 8 weeks, and had inadequate response to >= 1 and