Thriving Mind South Florida, Miami, Florida.
Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.
J Clin Psychiatry. 2023 Aug 28;84(5):23m14786. doi: 10.4088/JCP.23m14786.
Certain atypical antipsychotics, while efficacious as adjunctive treatments in major depressive disorder (MDD), are associated with metabolic adverse effects and weight gain. This analysis determined the effect of adjunctive brexpiprazole on metabolic parameters and body weight in adults with MDD and prediabetes (ie, at risk of developing diabetes) based on pooled data from 3 short-term studies and 1 long-term study. The short-term studies were 6-week, randomized, double-blind, placebo-controlled studies of adjunctive oral brexpiprazole 1-3 mg/d in outpatients with MDD ( criteria) and inadequate response to antidepressant treatment, conducted between June 2011 and May 2016. The long-term study was a 26- to 52-week, open-label extension study conducted between October 2011 and May 2017. was defined based on fasting serum glucose and glycated hemoglobin (HbA1c) levels. Shifts in diabetes status and shifts/changes in fasting metabolic parameters and body weight were determined. Most patients receiving adjunctive brexpiprazole maintained their baseline diabetes status in the short term (568/751; 75.6%) and long term (1,919/2,746; 69.9%). The incidence of categorical shifts in fasting metabolic parameters generally did not differ between treatment groups or between prediabetes and non-diabetes subgroups. Mean changes from baseline in metabolic parameters were small in the short term (all < 5 mg/dL) and long term (all < 6 mg/dL, except < 20 mg/dL for triglycerides). Moderate weight gain was observed in the short term (1.5 kg) and long term (3.4-4.1 kg). Adjunctive brexpiprazole had a limited impact on the metabolic profile of patients with MDD, regardless of diabetes status (prediabetes/non-diabetes). Data used in this post hoc analysis came from studies with ClinicalTrials.gov identifiers NCT01360645, NCT01360632, NCT02196506, and NCT01360866.
某些非典型抗精神病药物在治疗重度抑郁症（MDD）方面有效，但与代谢不良反应和体重增加有关。基于 3 项短期研究和 1 项长期研究的汇总数据，这项分析确定了辅助性布瑞哌唑对 MDD 合并糖尿病前期（即有发生糖尿病风险）患者代谢参数和体重的影响。这 3 项短期研究是 2011 年 6 月至 2016 年 5 月期间进行的 6 周、随机、双盲、安慰剂对照的辅助性口服布瑞哌唑 1-3mg/d 治疗 MDD（标准）和抗抑郁治疗反应不足患者的研究，共纳入 751 例患者；长期研究是 2011 年 10 月至 2017 年 5 月进行的 26 至 52 周开放性扩展研究，共纳入 2,746 例患者。糖尿病前期是基于空腹血清葡萄糖和糖化血红蛋白（HbA1c）水平定义的。确定了糖尿病状态的转变以及空腹代谢参数和体重的转变/变化。在短期（568/751；75.6%）和长期（1919/2746；69.9%）中，大多数接受辅助性布瑞哌唑治疗的患者保持了基线糖尿病状态。空腹代谢参数的分类变化发生率在治疗组之间或糖尿病前期和非糖尿病亚组之间没有差异。短期（所有<5mg/dL）和长期（所有<6mg/dL，除甘油三酯<20mg/dL 外）的代谢参数从基线的平均变化较小。短期和长期均观察到中等体重增加（分别为 1.5kg 和 3.4-4.1kg）。辅助性布瑞哌唑对 MDD 患者的代谢特征影响有限，无论糖尿病状态如何（糖尿病前期/非糖尿病）。这项事后分析使用的是 ClinicalTrials.gov 标识符为 NCT01360645、NCT01360632、NCT02196506 和 NCT01360866 的研究数据。
