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A Study of the Safety of Risperidone in the Treatment of Children and Adolescents With Conduct and Other Disruptive Behavior Disorders

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ClinicalTrials.gov Identifier: NCT00236470
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Condition or disease Intervention/treatment Phase
Disruptive Behavior Disorder Drug: risperidone Phase 3

Detailed Description:
This is an open-label study of an oral formulation of risperidone to be taken daily over 12 months by children and adolescents with conduct and other disruptive behavior disorders. It is an extension of a randomized, double-blind study (RIS-INT-79) comparing risperidone with placebo over 6 months in patients who had already shown response to the medication for a period of 12 weeks. Efficacy assessments include: the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF), a measure of symptoms of conduct and other disruptive behavior disorders; Visual Analogue Scale for the most troublesome symptom (VAS-MS), a scale ranging from not troublesome to extremely troublesome; Clinical Global Impression-Severity of Illness (CGI-Severity), a measure of overall severity of illness; Children's Global Assessment Scale (C-GAS), as assessment overall functioning. Safety evaluations include incidence of adverse events, physical examinations, laboratory tests (biochemistry, hematology, and urinalysis), and electrocardiograms (ECGs). Oral risperidone solution (1milligram/milliliter) daily for 1year. For patients weighing at least 50kg, start dose is 0.5ml/day. At investigator's discretion, dose may be increased (maximum 1.5ml/d over 5 days). Patients under 50kg start at 0.25ml/d, increased, if required, to maximum 0.75ml/d.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risperidone in the Treatment of Children and Adolescents With Conduct and Other Disruptive Behavior Disorders - an Open Label Follow-up Trial of CR002020
Study Start Date : January 2002
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone




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

Secondary Outcome Measures :
  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.


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236470


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
ClinicalTrials.gov Identifier: NCT00236470     History of Changes
Other Study ID Numbers: CR002149
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: January 2011

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Disruptive behavior disorder
risperidone
antipsychotropic agents
child
adolescent

Additional relevant MeSH terms:
Disease
Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Behavioral Symptoms
Neurodevelopmental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents