Risperidone versus risperidone plus sodium valproate for treatment of bipolar disorders: a randomized, double-blind clinical-trial.

S Mohammad Moosavi,Mani B Monajemi,Mahshid Ahmadi

doi:10.5539/gjhs.v6n6p163

Abstract

Objective:This study compared the efficacy of risperidone monotherapy with risperidone plus valproate in bipolar I disorder, manic phase. Some studies showed the efficacy of risperidone monotherapy in the treatment of bipolar disorder, so we examined this effectiveness in this clinical-trial study.Method:This 7-week, randomized, single-blind study included 48 bipolar I inpatients manic phase without psychotic features divided in risperidone group (n = 23) and risperidone plus sodium valproate group (n = 25). According to clinical symptoms, 3 categories: complete remission, partial remission and no remission were mentioned in weekly follow-up. Remission rate compared with survival analysis.Results:The results showed a significant difference in remission rate between risperidone monotherapy and risperidone plus sodium valproate at the 1st, 2nd and the 3rd week (p = 0.012, 0.023, 0.027 respectively), It means the remission rate in risperidone plus valproate group was higher in the first three weeks, but at the end of the seventh week, the difference was not statistically significant. There was no significant difference between the two groups in the development of adverse effects.Conclusions:Risperidone can be effective and well tolerated in both acute manic episodes of bipolar mood disorders.

Highlights

First Generation Antipsychotics (FGA) had been used for the treatment of acute mania
Some studies showed the efficacy of risperidone monotherapy in the treatment of bipolar disorder, so we examined this effectiveness in this clinical-trial study
The results showed a significant difference in remission rate between risperidone monotherapy and risperidone plus sodium valproate at the 1st, 2nd and the 3rd week (p = 0.012, 0.023, 0.027 respectively), It means the remission rate in risperidone plus valproate group was higher in the first three weeks, but at the end of the seventh week, the difference was not statistically significant

Summary

Introduction

First Generation Antipsychotics (FGA) had been used for the treatment of acute mania. Randomized, placebo-controlled trials have demonstrated efficacy of SGA (olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole), for treatment of acute manic phase of bipolar disorders (Tohen et al, 2000; Smulevich et al, 2005). In a 12-week, single-blind, placebo-controlled trial for acute mania, risperidone (1 to 6 mg/d) produced a response rate of 48%, similar to the response rate of 47% by haloperidol (2 to 12 mg/d) (Smulevich et al, 2005). Sachs et al assessed the efficacy and safety of risperidone as an adjunctive agent to mood stabilizers in the treatment of acute mania. Double-blind trial including patients with bipolar disorder (manic or mixed phase) who were inadequately responding to mood stabilizer (MS), risperidone, haloperidol or placebo was added. Yatham et al examined the efficacy of combination of MS with risperidone and showed that risperidone www.ccsenet.org/gjhs

Methods

Results

Conclusion