A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder
The Efficacy And Safety Of Flexible Dosage Ranges Of Risperidone Versus Placebo In The Treatment Of Manic Episodes Associated With Bipolar I Disorder.
1 other identifier
interventional
267
0 countries
N/A
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 who are suffering a manic episode.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2000
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 18, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedJanuary 14, 2011
January 1, 2011
November 18, 2005
January 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Young Mania Rating Scale (YMRS) total score from baseline to the end of treatment.
Secondary Outcomes (1)
Change from baseline to the end of treatment in Clinical Global Impression-Severity of Illness (CGI-S) scale, Global Assessment Scale (GAS), and Positive and Negative Syndrome Scale (PANSS) total score; incidence of adverse events throughout study.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hirschfeld RM, Keck PE Jr, Kramer M, Karcher K, Canuso C, Eerdekens M, Grossman F. Rapid antimanic effect of risperidone monotherapy: a 3-week multicenter, double-blind, placebo-controlled trial. Am J Psychiatry. 2004 Jun;161(6):1057-65. doi: 10.1176/appi.ajp.161.6.1057.
PMID: 15169694RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 18, 2005
First Posted
November 22, 2005
Study Start
December 1, 2000
Study Completion
May 1, 2002
Last Updated
January 14, 2011
Record last verified: 2011-01