A double-blind, randomized, and placebo-controlled trial of buspirone added to
risperidone in patients with chronic schizophrenia.
Author(s): Ghaleiha A, Noorbala AA, Farnaghi F, Hajiazim M, Akhondzadeh S.
Affiliation(s): Research Center for Behavioral Disorders and Substance Abuse, Hamadan University
of Medical Sciences, Hamadan, Iran.
Publication date & source: 2010, J Clin Psychopharmacol. , 30(6):678-82
OBJECTIVE: The role of partial agonism at 5-HT1A receptors in general and of
buspirone in particular remains unclear in the treatment of negative symptoms of
schizophrenia. This study was designed to investigate the effect of buspirone
added to risperidone as augmentation therapy in patients with chronic
schizophrenia and prominent negative symptoms in a double-blind randomized
clinical trial.
METHODS: The participants were 31 men and 15 women aged 19 to 44 years who were
inpatients at 2 psychiatric teaching hospitals in Iran. All patients were
inpatients and were in the active phase of the illness and met the Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria
for schizophrenia. Patients were allocated in a random fashion: 23 patients to
risperidone at 6 mg/d plus buspirone at 60 mg/d and 20 patients to risperidone at
6 mg/d plus placebo. The outcome was measured using the Positive and Negative
Syndrome Scale.
RESULTS: The buspirone group had significantly greater improvement in the
negative symptoms and positive general psychopathology subscales and Positive and
Negative Syndrome Scale total scores over the 8-week trial. Therapy with 60 mg of
buspirone per day was well tolerated, and no clinically important adverse effects
were observed.
CONCLUSIONS: The present study indicates buspirone as a potential adjunctive
treatment strategy for the treatment of schizophrenia, in particular, negative
symptoms. Nevertheless, results of larger controlled trials are needed before
recommendation for a broad clinical application can be made. This trial is
registered with the Iranian Clinical Trials Registry (IRCT138712051556N8).
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