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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.

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00154362
Enrollment
50
Registered
2005-09-12
Start date
2003-04-30
Completion date
2004-10-31
Last updated
2011-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conduct Disorder

Keywords

Oxcarbazepine, conduct disorder, adolescents

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.

Interventions

DRUGOxcarbazepine

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
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/

Design outcomes

Primary

MeasureTime frame
Percentage reduction on Impulsivity Rating Scale (IRS)

Secondary

MeasureTime frame
Percent reduction in the Modified Overt Aggression Scale (MOAS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026