Status:
COMPLETED
The Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-term Treatment of Bipolar Mania
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 su...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00216554
Start Date
September 1 2004
End Date
March 1 2006
Last Update
January 24 2011
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