A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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 psychological therapy.

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

Details

• Lead Sponsor: Janssen-Cilag Ltd.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.