Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone Compared With Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder, and the Maintenance of Anti-manic Effectiveness of Risperidone Compared With Haloperidol
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Bipolar Disorders
Manic Disorder
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) compared with placebo after 3 weeks of treatment in patients with bipolar disorder who a...
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 diagnosis criteria for Bipolar I Disorder - Most Recent Episode Manic (Diagnostic and Statistical Manual of Mental Diseases, 4th edition, (DSM-IV))
- meets DSM-IV criteria for a current manic episode
- hospitalized voluntarily at study initiation
- history of at least one documented manic or mixed episode prior to study initiation
- total score of \>=20 on the Young Mania Rating Scale (YMRS) and total score of \<=20 on the Montgomery Asberg Depression Rating Scale (MADRS) 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 :
September 1 2002
Estimated Enrollment :
439 Patients enrolled
Trial Details
Trial ID
NCT00253162
Start Date
March 1 2001
End Date
September 1 2002
Last Update
January 28 2011
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