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Efficacy of adjunctive aripiprazole in patients with major depressive disorder whose symptoms worsened with antidepressant monotherapy

机译:抗抑郁药单药治疗症状严重的重度抑郁症患者的辅助性阿立哌唑疗效

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Introduction. Efficacy of depression treatments, including adjunctive antipsychotic treatment, has not been explored for patients with worsening symptoms after antidepressant therapy (ADT). Methods. This post-hoc analysis utilized pooled data from 3 similarly designed, randomized, double-blind, placebo-controlled trials that assessed the efficacy, safety, and tolerability of adjunctive aripiprazole in patients with major depressive disorder with inadequate response to ADT. The studies had 2 phases: an 8-week prospective ADT phase and 6-week adjunctive (aripiprazole or placebo) treatment phase. This analysis focused on patients whose symptoms worsened during the prospective 8-week ADT phase (worsening defined as >0% increase in Montgomery-A?sberg Depressive Rating Scale [MADRS] Total score). During the 6-week, double-blind, adjunctive phase, response was defined as ≥50% reduction in MADRS Total score and remission as ≥50% reduction in MADRS Total score and MADRS score ≤10. Results. Of 1065 patients who failed to achieve a response during the prospective phase, 160 exhibited worsening of symptoms (ADT-Worseners), and 905 exhibited no change/reduction in MADRS scores (ADT-Non-worseners). Response rates for ADT-Worseners at endpoint were 36.6% (adjunctive aripiprazole) and 22.5% (placebo). Similarly, response rates at endpoint for ADT-Non-worseners were 37.5% (adjunctive aripiprazole) and 22.5% (placebo). Remission rates at endpoint for ADT-Worseners were 25.4% (adjunctive aripiprazole) and 12.4% (placebo). For ADT-Non-worseners, remission rates were 29.9% (adjunctive aripiprazole) and 17.4% (placebo). Conclusion. These results suggest that adjunctive aripiprazole is an effective intervention for patients whose symptoms worsen during antidepressant monotherapy. The results challenge the view that benefits of adjunctive therapy with aripiprazole are limited to partial responders to ADT.
机译:介绍。对于抗抑郁治疗(ADT)后症状恶化的患者,尚未探索包括辅助抗精神病药物在内的抑郁治疗的功效。方法。这项事后分析利用了来自3个类似设计,随机,双盲,安慰剂对照试验的汇总数据,这些试验评估了辅助性阿立哌唑在重症抑郁症患者中对ADT反应不足的疗效,安全性和耐受性。研究分为两个阶段:一个为期8周的ADT前瞻性阶段和一个为期6周的辅助(阿立哌唑或安慰剂)治疗阶段。这项分析的重点是在预期的8周ADT阶段症状加重的患者(恶化定义为Montgomery-A?sberg抑郁评分量表[MADRS]总评分增加> 0%)。在6周的双盲辅助阶段中,将缓解定义为MADRS总得分降低≥50%,将缓解定义为MADRS总得分降低且≥50%,并将MADRS得分≤10。结果。在前瞻性阶段未达到反应的1065例患者中,有160例症状恶化(ADT-Worseners),而905例MADRS评分无变化/降低(ADT-Woreners)。终点时ADT-Worseners的缓解率为36.6%(阿立哌唑辅助)和22.5%(安慰剂)。同样,ADT-非-增白剂的终点缓解率为37.5%(阿立哌唑辅助)和22.5%(安慰剂)。 ADT-Woreners的终点缓解率是25.4%(辅助性阿立哌唑)和12.4%(安慰剂)。对于非ADT-Wornereners,缓解率分别为29.9%(阿立哌唑辅助)和17.4%(安慰剂)。结论。这些结果表明,辅助阿立哌唑是抗抑郁单一疗法期间症状恶化的患者的有效干预措施。该结果挑战了以下观点:阿立哌唑辅助治疗的益处仅限于对ADT的部分反应。

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