Status:
COMPLETED
A Study of the Safety of Risperidone in the Treatment of Children and Adolescents With Conduct and Other Disruptive Behavior Disorders
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Disruptive Behavior Disorder
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
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 diso...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00236470
Start Date
January 1 2002
End Date
July 1 2004
Last Update
June 8 2011
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