Status:
COMPLETED
A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children
Lead Sponsor:
Janssen-Cilag Ltd.
Conditions:
Learning Disorders
Child Behavior Disorders
Eligibility:
All Genders
5-16 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess whether risperidone (an antipsychotic medication) is safe and effective in treating behaviour disorder in learning disabled children, which does not improve with...
Detailed Description
There is a high incidence of behaviour disorder in people who are learning disabled. The purpose of this study is to assess whether risperidone is safe and effective in the treatment of learning disab...
Eligibility Criteria
Inclusion
- DSM-IV Axis II diagnosis of mental retardation
- behavioural and family therapy tried for 6 months but has failed
- in school, at least part time
- score of \>=8 on hostility scale
- subject is otherwise healthy
Exclusion
- Patients with a seizure disorder requiring repeated change of medication
- extrapyramidal symptoms not well controlled by medication
- abnormal and clinically significant electrocardiogram (ECG) changes
- history of tardive dyskinesia (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs), or neuroleptic malignant syndrome (a rare condition in patients receiving antipsychotic medication in which patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state)
- known hypersensitivity to antipsychotic medications, including risperidone.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00254930
Start Date
September 1 2003
End Date
June 1 2006
Last Update
May 20 2011
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