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.
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Conduct Disorder
Intervention: Oxcarbazepine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Celso Arango, MD, Principal Investigator, Affiliation: Hospital Gregorio Marañón,Madrid, Spain
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Percentage reduction on Impulsivity Rating Scale (IRS)
Secondary outcome: Percent reduction in the Modified Overt Aggression Scale (MOAS)
Eligibility
Minimum age: 6 Years.
Maximum age: 16 Years.
Gender(s): 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.
Locations and Contacts
Additional Information
Starting date: April 2003
Last updated: November 22, 2011
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