Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Bipolar Disorder
Manic Episode
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo in treating mania during 3 weeks of treatment in patients with Bipolar I ...
Detailed Description
Antipsychotic agents have, for a long time, been used to alleviate the severe behavioral problems associated with manic episodes. Risperidone, widely used in the treatment of schizophrenia, has been s...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed
- hospitalized voluntarily at study initiation for treatment of manic episode
- history (prior to study initiation) of at least one documented manic or mixed episode that required treatment
- total score \>=20 on the Young Mania Rating Scale (YMRS) at start of the study
Exclusion
- Meets DSM-IV criteria for Schizoaffective Disorder or for rapid cycling
- borderline or antisocial personality disorder
- history of substance dependence (excluding nicotine and caffeine) within the 3 months prior to study initiation
- seizure disorder
- females who are pregnant or nursing, or those lacking adequate contraception.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00249236
Start Date
March 1 2001
End Date
December 1 2001
Last Update
January 14 2011
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