Ann Pharmacother. 2007 Jun;41(6):1005-12. Epub 2007 May 22.
Modafinil augmentation for residual symptoms of fatigue in patients
with a partial response to antidepressants
Lam JY, Freeman MK, Cates ME.
University of Alabama Health System-Birmingham, Birmingham, AL, USA.
OBJECTIVE: To evaluate the literature discussing the
use of modafinil in the treatment of residual symptoms of fatigue in patients
with depression.
DATA SOURCES: PubMed (1966-March 2007) and International
Pharmaceutical Abstracts (1970-March 2007) were searched using the key
words modafinil and depression. A manual search of the reference section
of the articles retrieved was conducted to identify articles not indexed
in either of these sources.
STUDY SELECTION AND DATA EXTRACTION: All articles published
in English were evaluated. Studies were included if modafinil was used
to treat patients with residual fatigue from depression and the effects
were measured with validated fatigue subscales.
DATA SYNTHESIS: One retrospective study, 5 open-label
trials, and 2 randomized controlled clinical trials met the inclusion
criteria for assessment of residual symptoms of fatigue as assessed by
commonly used fatigue subscales after modafinil administration. Although
improvement with fatigue has occurred with modafinil therapy, literature
regarding the topic is limited by the lack of well-controlled clinical
trials. Modafinil does appear to improve residual fatigue with depression
as evidenced by open-label trials; however, the efficacy of this agent
has not been duplicated in randomized controlled trials. The open-label
trials that have been conducted often had no comparator and a small number
of patients. In addition, outcome measures used in the studies were not
consistent between trials. Modafinil appears to be well tolerated, with
the main adverse effects being headache and nausea.
CONCLUSIONS: Open-label trials indicate that modafinil
may be effective in ameliorating fatigue associated with depression; however,
this effect has not been reproduced in randomized, double-blind, placebo-controlled
clinical trials. Therefore, the use of modafinil for the treatment of
residual fatigue is not recommended due to the lack of reproducible data
of its efficacy. Long-term, adequately powered clinical trials should
be conducted to determine its place in therapy.
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