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NCT00154362 Clinical Trial

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.

Conduct Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00154362
Other study ID # CTRI476BES04
Secondary ID
Status Completed
Phase Phase 4
First received September 8, 2005
Last updated November 22, 2011
Start date April 2003
Est. completion date October 2004

Study information
Verified date November 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date October 2004
Est. primary completion date October 2004
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 16 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Oxcarbazepine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage reduction on Impulsivity Rating Scale (IRS)
Secondary Percent reduction in the Modified Overt Aggression Scale (MOAS)
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