Double-Blind, Placebo-Controlled Study of Modafinil for Fatigue and Cognition in Schizophrenia Patients Treated With Psychotropic Medications
J Clin Psychiatry 2005;66(7):839-843
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: To assess the effects of modafinil on
fatigue, symptoms, attention, working memory, and executive
functioning in schizophrenia patients treated with psychotropic
Method: Twenty-four patients with a DSM-IV
diagnosis of schizophrenia or schizoaffective disorder (10 men
and 14 women) were randomly assigned to modafinil up to 200 mg a
day (N = 13) or placebo (N = 11) as an adjunct therapy in an 8-week,
double-blind, placebo-controlled study. Data were collected from
May 18, 2001 to September 11, 2003.
Results: Four subjects terminated the study
early, including one because of worsening of psychosis during the
first week taking modafinil. In the modafinil (N = 10) and placebo
(N = 10) groups, fatigue improved significantly over time
(p < .01), but there were no differences between groups on
changes in fatigue, positive and negative symptoms, or cognition.
Conclusion: Fatigue improved in both groups, and
there were no differences between groups on changes in fatigue,
symptoms, attention, working memory, or executive functioning.
Lack of differences between groups may be due to small sample
size or possible regression to the mean in the placebo group.