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.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00154362
First received: September 8, 2005
Last updated: November 22, 2011
Last verified: November 2011
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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:
Disease
Conduct Disorder
Aggression
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Behavioral Symptoms
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014