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

Novartis0 sites50 target enrollmentApril 2003

ConditionsConduct Disorder

DrugsOxcarbazepine

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Conduct Disorder
Sponsor: Novartis
Enrollment: 50
Primary Endpoint: Percentage reduction on Impulsivity Rating Scale (IRS)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

October 2004

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

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.