Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00254930
Status:
COMPLETED
Last Update Posted:
2011-05-20
First Post:
2005-11-15
Brief Title:
A Prospective Study of Risperdal Risperidone for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children
Sponsor:
Janssen-Cilag Ltd
Organization:
Janssen-Cilag Ltd
Study Overview
Official Title:
Prospective Trial of Risperdal Risperidone Following Psychological Therapy for Challenging Behaviour in Learning Disabled Children
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 psychological therapy
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 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 025 mgday up to a maximum of 4 mgday 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 025 mg of risperidone per day taken orally up to a maximum daily dose of 4 mgday for a treatment period of 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None