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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.

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

Page last updated: August 23, 2015

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