Overview

A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder

Status:
Completed
Trial end date:
2002-05-01
Target enrollment:
0
Participant gender:
All
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 who are suffering a manic episode.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatments:
Risperidone
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.