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.

Condition(s) targeted: Conduct Disorder

Intervention: Oxcarbazepine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Celso Arango, MD, Principal Investigator, Affiliation: Hospital Gregorio Marañón,Madrid, Spain

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Percentage reduction on Impulsivity Rating Scale (IRS)

Secondary outcome: Percent reduction in the Modified Overt Aggression Scale (MOAS)

Minimum age: 6 Years. Maximum age: 16 Years. Gender(s): Both.

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.

Starting date: November 2003
Ending date: December 2006
Last updated: November 29, 2007