Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.
Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, India.
J Clin Pharmacol. 2022 Jun;62(6):721-732. doi: 10.1002/jcph.2022. Epub 2022 Feb 8.
Serotonin-dopamine activity modulators (SDAMs) have been approved as an adjunctive treatment to antidepressants in patients with inadequate response. These drugs have been proposed to have a beneficial effect on cognition, sleep-related problems, and other affective symptoms in patients with depression. Previous studies have shown inconsistent evidence and have not reported a pooled effect of the 2 drugs of this class: aripiprazole and brexpiprazole. This meta-analysis evaluated the effect of augmentation with SDAM drugs in patients with major depression. The meta-analysis protocol was made as per Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol guidelines and registered in the International Prospective Register of Ongoing Systematic Reviews. The PubMed/MEDLINE, Cochrane Clinical Trial registry, and EudraCT databases were searched with prespecified search terms. A random-effects meta-analysis was performed using the meta package in R software. Fifteen studies were included in this meta-analysis. The random-effects model analysis observed a pooled effect of 1.55 (95%CI, 1.32-1.84; prediction interval, 0.95-2.55, z = 5.19 [P < .0001]) for remission between the SDAM and placebo groups. A pooled effect of 1.58 (95%CI, 1.37-1.83; prediction interval, 1.00-2.51, z = 6.34 [P < .0001]) for adverse events and 0.72 (95%CI, 0.48-1.08; prediction interval, 0.46-1.12; z = -1.58 [P = .113]) for serious adverse events was observed. No significant publication bias was noticed. The quality of the evidence was rated as high. Adjunct SDAM increased remission in patients and had no significant effect on serious adverse events compared to placebo. Therefore, we conclude that SDAM drugs can be an effective and safe antidepressant augmentation strategy in patients with major depressive disorder.
血清素-多巴胺活性调节剂 (SDAMs) 已被批准作为抗抑郁药的辅助治疗药物，用于治疗反应不足的患者。这些药物被认为对抑郁症患者的认知、睡眠相关问题和其他情感症状有有益的影响。先前的研究结果不一致，并且没有报告这一类药物（阿立哌唑和布瑞哌唑）的汇总效果。这项荟萃分析评估了 SDAM 药物增强治疗对重度抑郁症患者的疗效。荟萃分析方案是根据系统评价和荟萃分析报告的首选报告项目指南制定的，并在国际前瞻性正在进行的系统评价注册中心注册。使用预定义的搜索词在 PubMed/MEDLINE、Cochrane 临床试验注册中心和 EudraCT 数据库中进行搜索。使用 R 软件中的 meta 包进行随机效应荟萃分析。这项荟萃分析纳入了 15 项研究。随机效应模型分析观察到 SDAM 组与安慰剂组之间缓解的汇总效应为 1.55（95%CI，1.32-1.84；预测区间，0.95-2.55，z = 5.19 [P <.0001]）。观察到不良事件的汇总效应为 1.58（95%CI，1.37-1.83；预测区间，1.00-2.51，z = 6.34 [P <.0001]）和严重不良事件的汇总效应为 0.72（95%CI，0.48-1.08；预测区间，0.46-1.12；z = -1.58 [P =.113]）。未发现明显的发表偏倚。证据质量被评为高。与安慰剂相比，辅助 SDAM 增加了患者的缓解率，并且对严重不良事件没有显著影响。因此，我们得出结论，SDAM 药物可以成为重度抑郁症患者有效且安全的抗抑郁药增强策略。
