NCT00250354

Brief Summary

The purpose of the study is to assess the safety and effectiveness of oral risperidone (an antipsychotic medication) in the treatment of conduct disorder and other disruptive behavior disorders in children ages 5 to 12 with mild, moderate, or borderline mental retardation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 1997

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1999

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

November 4, 2005

Last Update Submit

January 20, 2011

Conditions

Conduct DisorderOppositional Defiant DisorderDisruptive Behavior Disorder

Keywords

conduct disorderoppositional deficit disorderdisruptive behavior disorder not otherwise specifiedADHDrisperidoneantipsychotropic agentschildren

Outcome Measures

Primary Outcomes (1)

  • Change in the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF) at end of treatment compared with baseline.

Secondary Outcomes (1)

  • Changes in Aberrant Behavior Checklist (ABC), Behavioral Problems Inventory (BPI), and Clinical Global Impression (CGI) at end of treatment compared with baseline; incidence of adverse events throughout study.

Interventions

Risperidone oral solutionDRUG

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meets Axis I diagnosis criteria for Conduct Disorder or Oppositional Defiant Disorder or Disruptive Behavior Disorder not otherwise specified (DSM-IV, Diagnostic and Statistical Manual of Mental Diseases, 4th edition) and has a total rating of \>=24 on the Nisonger Child Behavior Rating Form (N-CBRF) Conduct Problem Subscale. (Patients with conduct disorder who also meet DSM-IV criteria for Attention Deficit/Hyperactivity Disorder (AD/HD) are eligible.)
  • meets DSM-IV Axis II diagnosis criteria for Mild Mental Retardation, Moderate Mental Retardation or Borderline Intellectual Functioning (diagnoses that represent intelligence quotients \[IQs\] ranging from 35 to 84)

You may not qualify if:

  • DSM-IV diagnosis of Pervasive Development Disorder, Schizophrenia, or Other Psychotic Disorders
  • head injury as cause of mental impairment
  • seizure disorder currently requiring medication
  • history of tardive dyskinesia (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
  • known hypersensitivity, intolerance, or unresponsiveness to risperidone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Snyder R, Turgay A, Aman M, Binder C, Fisman S, Carroll A; Risperidone Conduct Study Group. Effects of risperidone on conduct and disruptive behavior disorders in children with subaverage IQs. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1026-36. doi: 10.1097/00004583-200209000-00002.

    PMID: 12218423RESULT

MeSH Terms

Conditions

Conduct DisorderOppositional Defiant DisorderAttention Deficit and Disruptive Behavior DisordersAttention Deficit Disorder with Hyperactivity

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen Pharmaceutica N.V. Clinical Trial

    Janssen Pharmaceutica N.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 8, 2005

Study Start

September 1, 1997

Study Completion

August 1, 1999

Last Updated

January 24, 2011

Record last verified: 2011-01