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

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.

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Key information

Conditions

Disruptive Behavior Disorder Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risperidone

Drug

Primary outcomes

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Risperidone in the Treatment of Children and Adolescents With Conduct and Other Disruptive Behavior Disorders - an Open Label Follow-up Trial of CR002020

Important dates

Study start: 2002
Study completion: 2004
First posted: Oct 12, 2005
Registry last updated: Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed