A placebo-controlled study of the modafinil added to risperidone in chronic
schizophrenia.
Author(s): Arbabi M, Bagheri M, Rezaei F, Ahmadi-Abhari SA, Tabrizi M, Khalighi-Sigaroudi F,
Akhondzadeh S.
Affiliation(s): Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of
Medical Sciences, South Kargar Street, Tehran, 13337, Iran.
Publication date & source: 2012, Psychopharmacology (Berl). , 220(3):591-8
RATIONAL: In recent years, evidence suggests that modafinil may be useful for
certain symptom domains of schizophrenia, especially for the negative and
cognitive symptoms. However, the results are not consistent.
OBJECTIVE: This study was designed to investigate the effect of modafinil added
to risperidone in patients with chronic schizophrenia in a double blind and
randomized clinical trial.
METHODS: Participants were inpatients males (35) and females (11), ages 20-49
years at two teaching psychiatric hospital in Iran. All patients were in the
active phase of the illness and met DSM-IV-TR criteria for schizophrenia.
Patients were allocated in a random fashion 23 patients to risperidone 6 mg/day
plus modafinil 200 mg/day and 23 patients to risperidone 6 mg/day plus placebo.
The principal measure of outcome was the positive and negative syndrome scale
(PANSS). Patients were assessed by a psychiatrist at baseline and after 2, 4, 6
and 8 weeks after the start of medication.
RESULTS: The modafinil group had significantly greater improvement in the
negative symptoms as well as PANSS total scores over the 8-week trial. Therapy
with 200 mg/day of modafinil was well tolerated and no clinically important side
effects were observed.
CONCLUSION: The present study indicates modafinil as a potential adjunctive
treatment strategy for treatment of schizophrenia particularly the negative
symptoms. Nevertheless, results of larger-controlled trials are needed before
recommendation for broad clinical application can be made.
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