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: 2011-09-24, Psychopharmacology (Berl)., [Epub ahead of print]
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. This trial is registered with the Iranian Clinical Trials Registry (IRCT138903131556N16).