Treatment of HIV-related fatigue with armodafinil: a placebo-controlled
randomized trial.
Author(s): Rabkin JG, McElhiney MC, Rabkin R.
Affiliation(s): New York State Psychiatric Institute and Department of Psychiatry, College of
Physicians and Surgeons, Columbia University, 1051 Riverside Drive, New York, NY
10032, USA. jgr1@columbia.edu
Publication date & source: 2011, Psychosomatics. , 52(4):328-36
OBJECTIVE: To evaluate the efficacy and safety of armodafinil in the treatment of
fatigue in HIV+ patients, and to assess its effect on depressive symptoms and
behavior once fatigue remitted.
METHOD: HIV+ patients with clinically significant fatigue were treated in a
placebo-controlled randomized double-blind trial for 4 weeks. Armodafinil
responders and placebo non-responders or relapsers were treated openly for a
total of 16 weeks with armodafinil. The primary outcome measure for fatigue and
depression was the Clinical Global Impressions-Improvement Scale, supplemented by
the Fatigue Severity Scale, the Hamilton Depression Rating Scale, and the Beck
Depression Inventory. Safety was assessed with assays of CD4 cell count and HIV
RNA viral load and the SAFTEE side effects rating scale. Maximum trial dose of
armodafinil was 250 mg/d.
RESULTS: Seventy patients were enrolled. Attrition was 9%. In intention-to-treat
analyses, fatigue response rate to armodafinil was 75% and to placebo, 26%.
Armodafinil did not reduce depressive symptoms in the absence of improved energy,
but of those patients with an Axis I depressive disorder at study entry whose
energy improved, 82% experienced improved mood as well. Markers of immunologic
suppression did not change during treatment. At 6 months, those still taking
armodafinil had more energy and fewer depressive symptoms than those who were no
longer taking it.
CONCLUSIONS: As we found in our RCT of modafinil, armodafinil appears effective
and well tolerated in treating fatigue in HIV+ patients. Side effects were
minimal and most patients reported substantially improved energy and mood.
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