Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Bipolar Disorders
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 during 3 weeks of treatment of mania in patients with Bipolar I Disorder ...
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
- Patients with a diagnosis of Bipolar I Disorder, Most Recent Episode Manic, by the criteria in the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- voluntarily hospitalized at study initiation for the current manic episode
- history of at least one documented manic or mixed episode that required treatment 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
- Patients who meet DSM-IV criteria for Schizoaffective Disorder or for rapid cycling
- with borderline or antisocial personality disorder
- history of substance dependence (excluding nicotine and caffeine) within the 3 months prior to study initiation
- with seizure disorder
- females who are pregnant or nursing, or those lacking adequate contraception.
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2002
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT00257075
Start Date
December 1 2000
End Date
May 1 2002
Last Update
January 14 2011
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