Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents
Research on the Effectiveness of Risperidone in Bipolar Disorder in Adolescents and Children (REACH): A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Risperidone for the Treatment of Acute Mania in Bipolar I Disorder
1 other identifier
interventional
13
0 countries
N/A
Brief Summary
A clinical study to determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder (manic or mixed type) in children and adolescents aged 10 to 17 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2003
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, 2003
CompletedFirst Submitted
Initial submission to the registry
January 14, 2004
CompletedFirst Posted
Study publicly available on registry
January 16, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedJune 8, 2011
April 1, 2010
January 14, 2004
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in the total YMRS score from baseline at the 3-week endpoint
Secondary Outcomes (1)
Effects on secondary efficacy variables (YMRS response and onset of maintained response, Clinical Global Impression Scale - Bipolar Disorder [CGI-BP]), safety, tolerability, and pharmacokinetics.
Interventions
Eligibility Criteria
You may qualify if:
- Current primary diagnosis of bipolar I disorder, mania or mixed type
- Aged between 10 and 17 years
- Young Mania Rating Scale score greater than or equal to 20 at screening and baseline
You may not qualify if:
- Known or suspected history of substance dependence
- Significant risk for suicidal or violent behavior
- Received electroconvulsive treatment within 4 weeks of baseline
- Received a depot antipsychotic within 2 treatment cycle before baseline
- Is unable to swallow medication taken in the form of tablets
- Has a positive result for a urine drug screen done at baseline
- Known or suspected seizure disorder
- Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening
- Known or suspected history of hypersensitivity or intolerance to risperidone
- History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
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
January 14, 2004
First Posted
January 16, 2004
Study Start
December 1, 2003
Study Completion
December 1, 2005
Last Updated
June 8, 2011
Record last verified: 2010-04