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

Bipolar Disorder Clinical Trial

Official title:

A Multicenter, Open-Label Study to Evaluate Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-term Treatment of Bipolar Mania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216554
• Other study ID #: CR005068
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: January 20, 2011
• Start date: September 2004
• Est. completion date: March 2006

Study information

• Verified date: January 2011
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• risperidone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in YMRS score from baseline at 6 months
Secondary	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