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.
This study has been completed.
Information provided by (Responsible Party):
First received: September 8, 2005
Last updated: November 22, 2011
Last verified: November 2011
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Percentage reduction on Impulsivity Rating Scale (IRS)
Secondary Outcome Measures:
- Percent reduction in the Modified Overt Aggression Scale (MOAS)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2004 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||6 Years to 16 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- History of conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified
- Score >8 on the Impulsivity Rating Scale
- 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.
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00154362
||Celso Arango, MD
||Hospital Gregorio Marañón,Madrid, Spain
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 8, 2005
||November 22, 2011
||Spain: Ministry of Health
Keywords provided by Novartis:
Oxcarbazepine, conduct disorder, adolescents
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2015
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers