A Study of the Efficacy and Safety of Risperidone in the Prevention of Relapse in Children and Adolescents With Conduct and Other Disruptive Behavior Disorders
Risperidone in the Prevention of Relapse: a Randomized, Double-blind, Placebo-controlled Trial in Children and Adolescents With Conduct and Other Disruptive Behavior Disorders.
1 other identifier
interventional
375
0 countries
N/A
Brief Summary
The purpose of this study is to assess the efficacy and safety of risperidone as maintenance therapy to prevent symptoms of relapse in children and adolescents with conduct and other disruptive behavior disorders, who initially responded well to treatment.
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 2001
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, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedJune 8, 2011
November 1, 2010
October 7, 2005
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from start of double-blind phase to relapse, using N-CBRF and CGI assessments.
Secondary Outcomes (1)
Comparison of ratings for risperidone and placebo on N-CBRF, CGI, and VAS-MS throughout study. Ratings on C-GAS once during each study phase. Comparison of safety profiles of risperidone and placebo (for example, adverse events, clinical and lab tests).
Interventions
Eligibility Criteria
You may qualify if:
- Patients must meet criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV) for Conduct Disorder, Oppositional Defiant Disorder, or Disruptive Behavior Disorder Not Otherwise Specified
- Have a score \>=24 on the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF)
- Have no other significant and untreated or unstable medical illness such as diabetes or hypertension, no serious illness of the liver, kidney, or significant disturbances of the cardiac, pulmonary, gastrointestinal, endocrine, or neurological system.
You may not qualify if:
- Patients who meet the DSM-IV criteria for: Pervasive Developmental Disorder
- schizophrenia or other psychotic disorders
- Tourette's Disorder
- Generalized Anxiety Disorder
- Major Depression
- Moderate or severe mental retardation
- Substance Dependence
- Patients with a history of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
- Hypersensitivity or intolerance to risperidone
- Pregnant or nursing females, or those lacking adequate contraception
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
October 7, 2005
First Posted
October 12, 2005
Study Start
December 1, 2001
Study Completion
September 1, 2003
Last Updated
June 8, 2011
Record last verified: 2010-11