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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00154362
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 24, 2011
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Conduct Disorder Drug: Oxcarbazepine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : April 2003
Primary Completion Date : October 2004
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Percentage reduction on Impulsivity Rating Scale (IRS)

Secondary Outcome Measures :
  1. Percent reduction in the Modified Overt Aggression Scale (MOAS)

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154362

Sponsors and Collaborators
Principal Investigator: Celso Arango, MD Hospital Gregorio Marañón,Madrid, Spain

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00154362     History of Changes
Other Study ID Numbers: CTRI476BES04
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 24, 2011
Last Verified: November 2011

Keywords provided by Novartis:
Oxcarbazepine, conduct disorder, adolescents

Additional relevant MeSH terms:
Impulsive Behavior
Conduct Disorder
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Behavioral Symptoms
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents