The Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-term Treatment of Bipolar Mania

Phase 4

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00216554
• Lead Sponsor: Janssen Korea, Ltd., Korea

Brief Summary

The purpose of this study is to evaluate effect of risperidone as a long-term combination therapy to mood stabilizers in the treatment of bipolar mania

Detailed Description

The use of mood stabilizers such as lithium and carbamazepine is known to be effective for preventing and treating bipolar disorder. But the use of antipsychotic drugs is more effective in patients suffering severe episodes of mania as it elicits behavioral changes and spurs the effects of mood stabilizers. Antipsychotic drugs are used for patients who failed to respond to mood stabilizers or for the acute management of manic episodes associated with bipolar disorders.

This study aims to evaluate the safety and efficacy of risperidone as an adjunctive therapy to mood stabilizers in the long-term treatment (6months) of bipolar disorder using various assessment instruments, including the Young Mania Rating Scale. The Simpson-Angus Rating Scale will be also employed to assess the presence of extrapyramidal side effects and other adverse events. The patients will receive orally 0.5, 1, 2 mg risperidone tablet once daily for 6 months

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Study Completion: 2006-03
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• In- or out-patient
• Diagnosis of bipolar I disorder
• most recent episode manic with or without psychotic features
• YMRS > 20 (manic)
• Need antipsychotic combination on the basis of clinicians' experience

Exclusion Criteria

• Rapid cycling
• Risk of suicide or violence
• History of Substance dependence within 3 months
• Comorbidities
• Unstable medical illness
• Previous sensitivity history to risperidone
• Pregnant woman or those without proper contraception
• History of clozapine and one cycle of depot use prior to entry
• History of treatment resistance: at least two mood stabilizers
• Prior history of active treatment with risperidone
• As for patients having wash-out period, patients that show 25% or more decrease in YMRS at baseline as compared to that at enrollment time, should be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The change in YMRS score from baseline at 6 months

Secondary Outcome Measures

Name	Time	Method
The change from baseline in Clinical Global Impression-Severity (CGI-S) score at 6 months; The change from baseline in HAMD score at 6 months