Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057408
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2003-04-01
Brief Title:
A Controlled Study of Olanzapine in Children With Autism
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
A Controlled Study of Olanzapine in Children With Autism
Status:
COMPLETED
Status Verified Date:
2011-09
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:
This is a 12-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with Autism in children aged 3 to 12 years old The first six weeks of the study are double-blind and placebo controlled meaning that patients receive either placebo or olanzapine and that neither the researchers nor the patients know whether or not they are receiving placebo or olanzapine In the second six weeks all of the patients receive olanzapine The purpose in using placebo is that it is otherwise impossible to know how effective the drug is or whether or not the drug causes side effects Patients treated with placebo can have improvement and can have side effects In the study patients receive a psychiatric evaluation physical examination laboratory tests and study medication olanzapine or placebo free of charge
Detailed Description:
None
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