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

NCT ID: NCT00216554

Last Updated: 2011-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2006-03-31

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

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

risperidone

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Principal Investigators

Janssen Korea, Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd.

Other Identifiers

CR005068

Identifier Type: -

Identifier Source: org_study_id