A double-blind, randomized, and placebo-controlled trial of buspirone added to risperidone in patients with chronic schizophrenia.

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).

A placebo controlled study of the propentofylline added to risperidone in chronic schizophrenia.

Impaired activity of the purinergic system is a plausible common factor that could be responsible for many aspects of schizophrenia. Based on purinegic hypothesis of schizophrenia, pharmacological treatments enhancing adenosine activity could be effective treatment in schizophrenia. Propentofylline is a novel xantine derivative which is being developed for treatment of degenerative and vascular dementia. It enhances extracellular adenosine level via inhibition of adenosine uptake. The purpose of the present investigation was to assess the efficacy of propentofylline as an adjuvant agent in the treatment of chronic schizophrenia in an 8-week double blind and placebo controlled trial. Eligible participants in this study were 50 patients with chronic schizophrenia. All patients were inpatients and were in the active phase of the illness, and met DSM-IV-TR criteria for schizophrenia. Patients were allocated in a random fashion, 25 to risperidone 6 mg/day plus propentofylline 900 mg/day (300 mg TDS) and 25 to risperidone 6 mg/day plus placebo. The principal measure of the outcome was Positive and Negative Syndrome Scale (PANSS). Although both protocols significantly decreased the score of the positive, negative and general psychopathological symptoms over the trial period, the combination of risperidone and propentofylline showed a significant superiority over risperidone alone in the treatment of positive symptoms, general psychopathology symptoms as well as PANSS total scores. The means Extrapyramidal Symptoms Rating Scale for the placebo group were higher than in the propentofylline group over the trial. However, the differences were not significant. The present study indicates propentofylline as a potential adjunctive treatment strategy for chronic schizophrenia. Nevertheless, results of larger controlled trials are needed, before recommendation for a broad clinical application can be made.

Efficacy of selegiline add on therapy to risperidone in the treatment of the negative symptoms of schizophrenia: a double-blind randomized placebo-controlled study.

OBJECTIVE: It has been reported that selegiline, a Selective Monoamine Oxidase Inhibitor B (MAOI-B), at low doses would be helpful for treating negative symptoms in schizophrenia. Nevertheless, the results are contradictory so far. This study was designed to investigate the effect of selegiline added to risperidone as augmentation therapy in patients with chronic schizophrenia and prominent negative symptoms in an 8 week, double blind and randomized clinical trial. METHODS: Eligible participants in this study were 40 patients with chronic schizophrenia. All patients were inpatients and were in the active phase of the illness, and met DSM-IV-TR criteria for schizophrenia. Patients were allocated in a random fashion, 20 to risperidone 6 mg/day plus selegiline 10 mg/day (5 mg bid) and 20 to risperidone 6 mg/day plus placebo. The principal measure of the outcome was Positive and Negative Syndrome Scale (PANSS). RESULTS: Although both protocols significantly decreased the score of the positive, negative, and general psychopathological symptoms over the trial period, the combination of risperidone and selegiline showed a significant superiority over risperidone alone in decreasing negative symptoms and PANSS total scores. CONCLUSION: The present study indicates selegiline as a potential adjunctive treatment strategy for the negative symptoms of schizophrenia. Nevertheless, results of larger controlled trials are needed before recommendation for a broad clinical application can be made.