Double-blind, placebo-controlled study of modafinil for fatigue and cognition in schizophrenia patients treated with psychotropic medications.
OBJECTIVE
To assess the effects of modafinil on fatigue, symptoms, attention, working memory, and executive functioning in schizophrenia patients treated with psychotropic medications.


METHODS
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.


CONCLUSIONS
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.
Sevy
Serge
S
The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System, Glen Oaks, NY 11004, USA. sevy@lij.edu
Rosenthal
Murray H
MH
Alvir
Jose
J
Meyer
Sabina
S
Visweswaraiah
Hema
H
Gunduz-Bruce
Handan
H
Schooler
Nina R
NR
D000328:Adult; D001288:Attention / Q000187:drug effects; D001559:Benzhydryl Compounds / Q000494:pharmacology / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000494:pharmacology / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects; D003072:Cognition Disorders / Q000139:chemically induced* / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005221:Fatigue / Q000139:chemically induced* / Q000188:drug therapy*; D005260:Female; D005625:Frontal Lobe / Q000502:physiology; D006801:Humans; D008297:Male; D008568:Memory / Q000187:drug effects; D000077408:Modafinil; D009483:Neuropsychological Tests; D010919:Placebos; D011618:Psychotic Disorders / Q000188:drug therapy / Q000523:psychology; D011619:Psychotropic Drugs / Q000009:adverse effects* / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D016896:Treatment Outcome
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D010919:Placebos; D011619:Psychotropic Drugs; D000077408:Modafinil