title: A double-blind, randomized, and placebo-controlled trial of buspirone added to risperidone in patients with chronic schizophrenia.
abstract: 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).
authors.affiliation: Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.
authors.forename: Ali
authors.initials: A
authors.lastname: Ghaleiha
authors.forename: Ahmad Ali
authors.initials: AA
authors.lastname: Noorbala
authors.forename: Farhad
authors.initials: F
authors.lastname: Farnaghi
authors.forename: Mohammad
authors.initials: M
authors.lastname: Hajiazim
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use; D002065:Buspirone / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006784:Hospitals, Teaching; D006801:Humans; D007492:Iran; D008297:Male; D011446:Prospective Studies; D018967:Risperidone / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy* / Q000503:physiopathology; D012565:Schizophrenic Psychology; D058825:Serotonin 5-HT1 Receptor Agonists / Q000627:therapeutic use*; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D058825:Serotonin 5-HT1 Receptor Agonists; D017366:Serotonin Receptor Agonists; D018967:Risperidone; D002065:Buspirone