NCT00154362

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

1.5 years

First QC Date

September 8, 2005

Last Update Submit

November 22, 2011

Conditions

Conduct Disorder

Keywords

Oxcarbazepine, conduct disorder, adolescents

Outcome Measures

Primary Outcomes (1)

  • Percentage reduction on Impulsivity Rating Scale (IRS)

Secondary Outcomes (1)

  • Percent reduction in the Modified Overt Aggression Scale (MOAS)

Interventions

OxcarbazepineDRUG

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • History of conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified
  • Score \>8 on the Impulsivity Rating Scale

You may not qualify if:

  • Other serious medical or psychiatric conditions excluding conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified
  • Treatment with antiepileptic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Conduct Disorder

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CarbamazepineDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Celso Arango, MD

    Hospital Gregorio Marañón,Madrid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

April 1, 2003

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

November 24, 2011

Record last verified: 2011-11