School of Medicine and Department of Old Age Psychiatry, King's College London, London, United Kingdom.
J Clin Psychiatry. 2013 Nov;74(11):1101-7. doi: 10.4088/JCP.13r08560.
Current pharmacologic treatments for a depressive episode in unipolar major depressive disorder (MDD) and bipolar depression are limited by low rates of remission. Residual symptoms include a persistent low mood and neurovegetative symptoms such as fatigue. The objective of this study was to examine the efficacy and tolerability of augmentation of first-line therapies with the novel stimulant-like agent modafinil in MDD and bipolar depression.
MEDLINE/PubMed, PsycINFO, 1980-April 2013 were searched using the following terms: (modafinil or armodafinil) and (depressi* or depressed or major depressive disorder or major depression or unipolar or bipolar or dysthymi*). Inclusion criteria were as follows: randomized controlled trial (RCT) design, sample comprising adult patients (18-65 years) with unipolar or bipolar depression, diagnosis according to DSM-IV, ICD-10, or other well-recognized criteria, modafinil or armodafinil given as augmentation therapy in at least 1 arm of the trial, and publication in English in a peer-reviewed journal.
Double-blind, randomized, placebo-controlled clinical trials of adjunctive treatment with modafinil or armodafinil of standard treatment for depressive episodes in MDD and bipolar depression were selected.
Two independent appraisers assessed the eligibility of the trials. A random-effects meta-analysis with DerSimonian-Laird method was used. Moderator effects were evaluated by meta-regression.
Data from 6 RCTs, with a total of 910 patients with MDD or bipolar depression, consisting of 4 MDD RCTs (n = 568) and 2 bipolar depression RCTs (n = 342) were analyzed. The meta-analysis revealed significant effects of modafinil on improvements in overall depression scores (point estimate = -0.35; 95% CI, -0.61 to -0.10) and remission rates (odds ratio = 1.61; 95% CI, 1.04 to 2.49). The treatment effects were evident in both MDD and bipolar depression, with no difference between disorders. Modafinil showed a significant positive effect on fatigue symptoms (95% CI, -0.42 to -0.05). The adverse events were no different from placebo.
Modafinil is an effective augmentation strategy for acute depressive episodes, including for symptoms of fatigue, in both unipolar and bipolar disorders.
目前用于单相重性抑郁障碍（MDD）和双相抑郁的抑郁发作的药物治疗缓解率较低。残留症状包括持续的情绪低落和神经植物症状，如疲劳。本研究的目的是研究新型刺激剂类药物莫达非尼作为一线治疗药物的增效作用在 MDD 和双相抑郁中的疗效和耐受性。
使用以下术语在 MEDLINE/PubMed、PsycINFO 中进行了搜索，检索时间为 1980 年至 2013 年 4 月：（莫达非尼或阿莫达非尼）和（抑郁或抑郁或重性抑郁障碍或重度抑郁症或单相或双相或恶劣心境障碍）。纳入标准如下：随机对照试验（RCT）设计，样本包括单相或双相抑郁的成年患者（18-65 岁），根据 DSM-IV、ICD-10 或其他公认标准进行诊断，莫达非尼或阿莫达非尼作为试验的至少 1 个臂的增效治疗药物，以及以英文发表的同行评议期刊。
选择了双盲、随机、安慰剂对照的临床试验，以评估莫达非尼或阿莫达非尼作为单相 MDD 和双相抑郁发作的标准治疗的增效治疗。
两名独立的评估者评估了试验的合格性。使用 DerSimonian-Laird 方法进行随机效应荟萃分析。通过元回归评估调节效应。
对来自 6 项 RCT 的数据进行了分析，共有 910 例 MDD 或双相抑郁患者，包括 4 项 MDD RCT（n=568）和 2 项双相抑郁 RCT（n=342）。荟萃分析显示，莫达非尼对改善总体抑郁评分（点估计=-0.35；95%CI，-0.61 至-0.10）和缓解率（比值比=1.61；95%CI，1.04 至 2.49）有显著效果。治疗效果在单相和双相抑郁中均有显现，且在两种疾病之间无差异。莫达非尼对疲劳症状有显著的积极影响（95%CI，-0.42 至-0.05）。不良反应与安慰剂无差异。
莫达非尼是单相和双相障碍急性抑郁发作的有效增效策略，包括疲劳症状。
