A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.
The Safety And Efficacy Of Risperdal� (Risperidone) Versus Placebo As Add-On Therapy To Mood Stabilizers In The Treatment Of The Manic Phase Of Bipolar Disorder
1 other identifier
interventional
151
0 countries
N/A
Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo as add-on therapy to mood stabilizers, in the treatment of manic episodes associated with bipolar disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 1997
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
October 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 4, 2005
CompletedFirst Posted
Study publicly available on registry
November 8, 2005
CompletedNovember 25, 2010
November 1, 2010
November 4, 2005
November 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Young Mania Rating Scale (YMRS) total score from baseline to end of double-blind treatment
Secondary Outcomes (1)
Changes from baseline to end of double-blind treatment in Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI) - severity, and Hamilton Depression Rating Scale (HAMD); incidence of adverse events throughout study.
Interventions
Eligibility Criteria
You may qualify if:
- Patients hospitalized for mania with a score \>=20 on the Young Mania Rating Scale (YMRS). (Patients with symptoms of depression are eligible)
- diagnosis of Bipolar Disorder according to Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- receiving treatment with a mood stabilizer for a minimum of 2 weeks prior to study initiation, or beginning therapy with a mood stabilizer prior to treatment with study medication
- patients medically stable on the basis of physical examination, medical history and electrocardiogram results.
You may not qualify if:
- Other Axis I DSM-IV diagnosis (except nicotine or caffeine dependence)
- history of alcohol or drug abuse or dependence within 3 months of starting the study
- seizure disorder requiring medication
- known sensitivity to risperidone, lithium, valproate or carbamazepine
- pregnant or nursing females, or those lacking adequate contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Yatham LN, Grossman F, Augustyns I, Vieta E, Ravindran A. Mood stabilisers plus risperidone or placebo in the treatment of acute mania. International, double-blind, randomised controlled trial. Br J Psychiatry. 2003 Feb;182:141-7. doi: 10.1192/bjp.182.2.141.
PMID: 12562742RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutica N.V. Clinical Trial
Janssen Pharmaceutica N.V.
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 4, 2005
First Posted
November 8, 2005
Study Start
October 1, 1997
Study Completion
November 1, 1999
Last Updated
November 25, 2010
Record last verified: 2010-11