Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone as add-on Therapy to Mood Stabilizers in the Treatment of Manic Episodes Associated With Bipolar Disorder
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Bipolar Disorders
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 episode...
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
- Diagnosis of Bipolar Disorder according to Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- hospitalized for mania with a score \>=20 on the Young Mania Rating Scale (YMRS) (patients with concurrent symptoms of depression are eligible)
- inpatient for a minimum of the first 4 days of double-blind treatment
- therapy with lithium or valproate (mood stabilizers) at start of treatment with study medication
- 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 4 weeks of starting the study
- seizure disorder requiring medication
- known sensitivity to risperidone, haloperidol, lithium, valproate or carbamazepine
- pregnant or nursing females, or those lacking adequate contraception.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 1999
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00253149
End Date
April 1 1999
Last Update
January 24 2011
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