NCT00236470

Brief Summary

The primary purpose of this study is to document the long-term safety of an oral formulation of risperidone in the treatment of children and adolescents with conduct and other disruptive behavior disorders. Data on the efficacy of the drug will also be collected. Only patients who were enrolled in the previous related study would be eligible to participate.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2002

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

January 1, 2002

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

June 8, 2011

Status Verified

January 1, 2011

First QC Date

October 7, 2005

Last Update Submit

June 6, 2011

Conditions

Disruptive Behavior Disorder

Keywords

Disruptive behavior disorderrisperidoneantipsychotropic agentschildadolescent

Outcome Measures

Primary Outcomes (1)

  • To accumulate long-term safety data: incidence of adverse events and clinical evaluations (physical exam, laboratory tests) conducted throughout the trial.

Secondary Outcomes (1)

  • To asses long-term efficacy data: changes from baseline to 1 year in Conduct Problem subscale of N-CBRF; VAS-MS changes from baseline through 1 year; CGI-Severity subscale at every visit; C-GAS rated for global functioning at the endpoint.

Interventions

risperidoneDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have completed the double-blind study (CR002020)
  • Patients must begin the present study within 7 days of taking the last dose of medication in the prior study (CR002020)

You may not qualify if:

  • Patients with hypersensitivity or intolerance to risperidone
  • Patients with extrapyramidal symptoms (EPS) not adequately controlled with medication
  • History of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
  • Significant and untreated or unstable medical illness such as diabetes, hypertension
  • serious illness of the liver, kidney, or significant disturbances of the cardiac, pulmonary, gastrointestinal, endocrine, neurological system
  • Pregnant or nursing females, or those lacking adequate contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

January 1, 2002

Study Completion

July 1, 2004

Last Updated

June 8, 2011

Record last verified: 2011-01