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.

First Received on September 8, 2005. Last Updated on November 22, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00154362

Purpose

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.

Condition	Intervention	Phase
Conduct Disorder	Drug: Oxcarbazepine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Oxcarbazepine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Percentage reduction on Impulsivity Rating Scale (IRS)

Secondary Outcome Measures:

Percent reduction in the Modified Overt Aggression Scale (MOAS)

Enrollment:	50
Study Start Date:	April 2003
Study Completion Date:	October 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	6 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154362

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Celso Arango, MD

Hospital Gregorio Marañón,Madrid, Spain

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00154362 History of Changes
Other Study ID Numbers:	CTRI476BES04
Study First Received:	September 8, 2005
Last Updated:	November 22, 2011
Health Authority:	Spain: Ministry of Health

Keywords provided by Novartis:

Oxcarbazepine, conduct disorder, adolescents

Additional relevant MeSH terms:

Aggression
Impulsive Behavior
Conduct Disorder
Behavioral Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012