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: September 8, 2005 Last Updated: November 29, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	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

Drug Information available for: Oxcarbazepine

U.S. FDA Resources

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

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)

Estimated Enrollment:	60
Study Start Date:	November 2003
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	6 Years to 16 Years
Genders Eligible for Study:	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.

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

Study ID Numbers:	CTRI476BES04
Study First Received:	September 8, 2005
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00154362 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by Novartis:

Oxcarbazepine, conduct disorder, adolescents

Study placed in the following topic categories:

Conduct Disorder
Tranquilizing Agents
Oxcarbazepine
Psychotropic Drugs
Adjuvants, Immunologic
Central Nervous System Depressants
Attention Deficit and Disruptive Behavior Disorders
Antimanic Agents
Behavioral Symptoms

Carbamazepine
Mental Disorders
Analgesics, Non-Narcotic
Mental Disorders Diagnosed in Childhood
Analgesics
Peripheral Nervous System Agents
Aggression
Anticonvulsants

Additional relevant MeSH terms:

Conduct Disorder
Tranquilizing Agents
Disease
Oxcarbazepine
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Attention Deficit and Disruptive Behavior Disorders
Antimanic Agents
Pharmacologic Actions
Behavioral Symptoms
Pathologic Processes

Carbamazepine
Sensory System Agents
Analgesics, Non-Narcotic
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Peripheral Nervous System Agents
Analgesics
Aggression
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 06, 2009