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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Oxcarbazepine

Primary Measures

• Percentage reduction on Impulsivity Rating Scale (IRS)

Secondary Measures

• Percent reduction in the Modified Overt Aggression Scale (MOAS)

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 16 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Celso Arango, MD Principal Investigator Hospital Gregorio Marañón,Madrid, Spain  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00154362

Study ID Number: CTRI476BES04

ClinicalTrials.gov Identifier: NCT00154362

Health Authority: Spain: Ministry of Health