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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Risperidone

Criteria

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.