Modafinil augmentation therapy in unipolar and bipolar depression: a systematic
review and meta-analysis of randomized controlled trials.
Author(s): Goss AJ(1), Kaser M, Costafreda SG, Sahakian BJ, Fu CH.
Affiliation(s): Author information:
(1)School of Medicine and Department of Old Age Psychiatry, King's College London,
London, United Kingdom.
Publication date & source: 2013, J Clin Psychiatry. , 74(11):1101-7
OBJECTIVE: 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.
DATA SOURCES: 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.
STUDY SELECTION: 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.
DATA EXTRACTION: 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.
RESULTS: 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.
CONCLUSIONS: Modafinil is an effective augmentation strategy for acute depressive
episodes, including for symptoms of fatigue, in both unipolar and bipolar
disorders.
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