Back to resultsThe Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Adolescents With Impulsivity and Aggressive Behavior in Conduct Disorder This Study is Not Being Conducted in the United States.
Primary Purpose
Conduct Disorder
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oxcarbazepine
Sponsored by
About this trial
This is an interventional treatment trial for Conduct Disorder focused on measuring Oxcarbazepine, conduct disorder, adolescents
Eligibility Criteria
Inclusion Criteria: History of conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified Score >8 on the Impulsivity Rating Scale Exclusion Criteria: Other serious medical or psychiatric conditions excluding conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified Treatment with antiepileptic medications Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Percentage reduction on Impulsivity Rating Scale (IRS)
Secondary Outcome Measures
Percent reduction in the Modified Overt Aggression Scale (MOAS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00154362
Brief Title
The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Adolescents With Impulsivity and Aggressive Behavior in Conduct Disorder This Study is Not Being Conducted in the United States.
Official Title
A Multi-center, Randomized, Double-blind, Cross-over, Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Oxcarbazepine p.o. (300-1200 mg/Day) as Adjuvant Therapy for Impulsivity and Aggressive Behavior in Conduct Disorders in Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
Conduct disorder is a group of psychiatric symptoms that can include clinical characteristics of impulsivity and aggressive behavior. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of adolescents with conduct disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conduct Disorder
Keywords
Oxcarbazepine, conduct disorder, adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxcarbazepine
Primary Outcome Measure Information:
Title
Percentage reduction on Impulsivity Rating Scale (IRS)
Secondary Outcome Measure Information:
Title
Percent reduction in the Modified Overt Aggression Scale (MOAS)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified
Score >8 on the Impulsivity Rating Scale
Exclusion Criteria:
Other serious medical or psychiatric conditions excluding conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified
Treatment with antiepileptic medications
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso Arango, MD
Organizational Affiliation
Hospital Gregorio Marañón,Madrid, Spain
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Adolescents With Impulsivity and Aggressive Behavior in Conduct Disorder This Study is Not Being Conducted in the United States.
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