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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236444
First received: October 7, 2005
Last updated: June 6, 2011
Last verified: November 2010
  Purpose

The purpose of this study is to assess the efficacy and safety of risperidone as maintenance therapy to prevent symptoms of relapse in children and adolescents with conduct and other disruptive behavior disorders, who initially responded well to treatment.


Condition Intervention Phase
Attention Deficit and Disruptive Behavior Disorders
Drug: risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Risperidone in the Prevention of Relapse: a Randomized, Double-blind, Placebo-controlled Trial in Children and Adolescents With Conduct and Other Disruptive Behavior Disorders.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Time from start of double-blind phase to relapse, using N-CBRF and CGI assessments.

Secondary Outcome Measures:
  • Comparison of ratings for risperidone and placebo on N-CBRF, CGI, and VAS-MS throughout study. Ratings on C-GAS once during each study phase. Comparison of safety profiles of risperidone and placebo (for example, adverse events, clinical and lab tests).

Enrollment: 375
Study Start Date: December 2001
Study Completion Date: September 2003
Detailed Description:

This is a randomized, double-blind study to compare an oral formulation of risperidone with placebo when taken daily over 24 weeks by children and adolescents with conduct and other disruptive behavior disorders. Patients who do not respond to treatment after an initial 6-week open-label phase, or do not show continued response after 12 weeks, must leave the trial and will not enter into the 24-week double-blind phase. The principal measure of efficacy is the time to symptom relapse. Relapse is assessed by changes in following measures: the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF), a measure of symptoms of conduct and other disruptive behavior disorders and Clinical Global Impression-Severity of Illness (CGI-Severity), and a measure of overall severity of illness. Efficacy assessment also includes Clinical Global Impression-Change (CGI-C), an assessment of improvement, and Visual Analogue Scale for the most troublesome symptom (VAS-MS), which is a scale ranging from not troublesome to extremely troublesome, and Children's Global Assessment Scale (C-GAS), which is an assessment of overall functioning. Safety evaluations include incidence of adverse events, physical examinations, laboratory tests (biochemistry, hematology, and urinalysis), and electrocardiograms (ECGs). The study hypothesis is that daily treatment with an oral formulation of risperidone, compared with placebo, will result in a clinically significant difference in time to relapse, and is well tolerated by children and adolescents with conduct and other disruptive behavior disorders. Oral risperidone solution (1milligram[mg]/milliliter [ml]), daily for 36 weeks. Patients weighing at least 50 kilograms start at 0.5 ml/day and may increase up to.1.5 ml/day. Patients under 50kg start at 0.25ml/day and may increase to 0.75ml/day (maximum).

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV) for Conduct Disorder, Oppositional Defiant Disorder, or Disruptive Behavior Disorder Not Otherwise Specified
  • Have a score >=24 on the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF)
  • Have no other significant and untreated or unstable medical illness such as diabetes or hypertension, no serious illness of the liver, kidney, or significant disturbances of the cardiac, pulmonary, gastrointestinal, endocrine, or neurological system.

Exclusion Criteria:

  • Patients who meet the DSM-IV criteria for: Pervasive Developmental Disorder
  • schizophrenia or other psychotic disorders
  • Tourette's Disorder
  • Generalized Anxiety Disorder
  • Major Depression
  • Moderate or severe mental retardation
  • Substance Dependence
  • Patients with a history of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
  • Hypersensitivity or intolerance to risperidone
  • Pregnant or nursing females, or those lacking adequate contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236444

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.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00236444     History of Changes
Other Study ID Numbers: CR002020
Study First Received: October 7, 2005
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Child
adolescent
disruptive behavior disorders
risperidone
antipsychotropic agents

Additional relevant MeSH terms:
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Disorder with Hyperactivity
Mental Disorders Diagnosed in Childhood
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 27, 2014