Official Title: “Prospective Trial of Risperdal® (Risperidone) Following Psychological Therapy for Challenging Behaviour in Learning Disabled Children”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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 disabled children diagnosed with behaviour disorder, which does not improve with psychological therapy. If the learning disability is very severe, or the behaviour disorder is very severe, such therapy is not appropriate and thus is not attempted; these patients are nevertheless eligible to participate in the study. At the beginning of treatment, the dose of risperidone is titrated, by gradual increase from 0.25 mg/day up to a maximum of 4 mg/day, based on therapeutic response, with decreases allowed in case of adverse reactions. Patients will be assessed over six months. The primary measure of effectiveness is the change compared to baseline in the total score on the Aberrant Behaviour Checklist (ABC). The EPSS is used to monitor the appearance of extrapyramidal symptoms. Based on results from other studies and the differences observed as a result of treatment, the investigator and his team expect to be able to detect a statistically and clinically significant result if data are available for 15 evaluable patients. Twenty patients will be recruited, taking account of possible drop outs.

0.25 mg of risperidone per day, taken orally, up to a maximum daily dose of 4 mg/day, for a treatment period of 6 months.

Intervention(s) in this Clinical Trial

• Drug: risperidone

Primary Measures

• Change compared to baseline in total score of the Aberrant Behaviour Checklist (ABC)

Secondary Measures

• Changes compared to baseline of Aberrant Behaviour Checklist (ABC) subclasses; hostility checklist; Clinical Global Impression (CGI) of severity; child quality of life rating scale

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen-Cilag Ltd.

Overall Clinical Trial Officials and Contacts

Janssen-Cilag Ltd. Clinical Trial Study Director Janssen-Cilag Ltd.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00254930

Study ID Number: CR005797

ClinicalTrials.gov Identifier: NCT00254930

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Prospective trial of risperidone (Risperdal) following psychological therapy for challenging behaviour in learning disabled children