Safety and tolerability of cariprazine for the adjunctive treatment of major depressive disorder: a pooled analysis of phase 2b/phase 3 clinical trials.

IF 2.1 3区 医学 Q3 PHARMACOLOGY & PHARMACY
Michael E Thase, Paul P Yeung, Ludmyla Rekeda, Meng Liu, Shane Varughese
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Abstract

To characterize the safety and tolerability of adjunctive cariprazine in patients with major depressive disorder (MDD) and inadequate response to monotherapy antidepressant treatment (ADT). Post hoc analyses evaluated pooled data from 2 fixed-dose phase 3 cariprazine studies (1.5 and 3 mg/d [approved doses for MDD]). In a separate safety analysis, cariprazine 0.1-4.5 mg/d was evaluated using data from the 2 fixed-dose trials plus 3 flexible-dose studies grouped by modal-daily dose. In the pooled phase 3 studies (placebo = 503, 1.5 mg/d = 502, 3 mg/d = 503), overall cariprazine-treated patients had high rates of study completion (90%). Patients had mostly mild/moderate treatment-emergent adverse events that caused premature discontinuation of 4.3%. Only akathisia, nausea, and insomnia occurred in ≥5% of cariprazine patients (any group) and at twice the rate of placebo; potential dose-dependent responses were observed for akathisia and insomnia. Cariprazine had a neutral metabolic profile, with mean weight increase of <1 kg. Modal-dose results were similar, and both analyses were consistent with the known safety profile of cariprazine across its approved indications. Adjunctive cariprazine therapy was safe and generally well tolerated in patients with MDD who had not obtained an adequate response to ADT monotherapy; no new safety signals were identified.

卡利普嗪辅助治疗重度抑郁障碍的安全性和耐受性:2b期/3期临床试验的汇总分析。
目的:描述对单药抗抑郁治疗(ADT)反应不佳的重度抑郁障碍(MDD)患者辅助使用卡哌嗪的安全性和耐受性。事后分析评估了 2 项固定剂量卡哌嗪 3 期研究(1.5 毫克/天和 3 毫克/天[用于 MDD 的批准剂量])的汇总数据。在一项单独的安全性分析中,使用来自 2 项固定剂量试验和 3 项灵活剂量研究的数据对卡普拉嗪 0.1-4.5 mg/d 进行了评估,这些数据按每日模式剂量分组。在汇总的 3 期研究中(安慰剂 = 503,1.5 毫克/天 = 502,3 毫克/天 = 503),卡哌嗪治疗患者的总体研究完成率较高(90%)。患者大多出现轻度/中度治疗突发不良事件,导致4.3%的患者过早停药。仅有≥5%的卡利普嗪患者(任何组别)出现了运动障碍、恶心和失眠,其发生率是安慰剂的两倍;在运动障碍和失眠方面观察到了潜在的剂量依赖性反应。卡哌嗪的代谢特征为中性,平均体重增加了
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来源期刊
CiteScore
4.40
自引率
23.10%
发文量
97
审稿时长
>12 weeks
期刊介绍: International Clinical Psychopharmacology provides an essential link between research and clinical practice throughout psychopharmacology. It reports on studies in human subjects, both healthy volunteers and patients, which relate the effects of drugs on psychological processes. A major objective of the journal is to publish fully refereed papers which throw light on the ways in which the study of psychotropic drugs can increase our understanding of psychopharmacology. To this end the journal publishes results of early Phase I and II studies, as well as those of controlled clinical trials of psychotropic drugs in Phase II and IV. Other topics covered include the epidemiology of psychotropic drug prescribing and drug taking, the sociology of psychotropic drugs including compliance, and research into the safety and adverse effects of these compounds.
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