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.

Phase 4

Completed

• Conditions: Conduct Disorder

• Registration Number: NCT00154362
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-22
• Last Update Posted: 2011-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Percentage reduction on Impulsivity Rating Scale (IRS)

Secondary Outcome Measures

Name	Time	Method
Percent reduction in the Modified Overt Aggression Scale (MOAS)