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.

NCT ID: NCT00154362

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Conduct Disorder

Keywords

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Oxcarbazepine, conduct disorder, adolescents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Oxcarbazepine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Celso Arango, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Gregorio Marañón,Madrid, Spain

Other Identifiers

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CTRI476BES04

Identifier Type: -

Identifier Source: org_study_id