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

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Risperidone

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