Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Bipolar Disorder
Manic Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo as add-on therapy to mood stabilizers, in the treatment of manic episod...
Detailed Description
Risperidone, widely used in the treatment of schizophrenia, has been shown to be effective in the treatment of manic and mixed episodes associated with bipolar disorders. Antipsychotic drugs like risp...
Eligibility Criteria
Inclusion
- Patients hospitalized for mania with a score \>=20 on the Young Mania Rating Scale (YMRS). (Patients with symptoms of depression are eligible)
- diagnosis of Bipolar Disorder according to Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- receiving treatment with a mood stabilizer for a minimum of 2 weeks prior to study initiation, or beginning therapy with a mood stabilizer prior to treatment with study medication
- patients medically stable on the basis of physical examination, medical history and electrocardiogram results.
Exclusion
- Other Axis I DSM-IV diagnosis (except nicotine or caffeine dependence)
- history of alcohol or drug abuse or dependence within 3 months of starting the study
- seizure disorder requiring medication
- known sensitivity to risperidone, lithium, valproate or carbamazepine
- pregnant or nursing females, or those lacking adequate contraception.
Key Trial Info
Start Date :
October 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 1999
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00250367
Start Date
October 1 1997
End Date
November 1 1999
Last Update
November 25 2010
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