Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183404
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2005-09-13
Brief Title:
Long-Term Olanzapine Treatment in Children With Autism
Sponsor:
Drexel University
Organization:
Drexel University
Study Overview
Official Title:
Long-Term Olanzapine Treatment in Children With Autism
Status:
COMPLETED
Status Verified Date:
2014-08
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 study will determine the short- and long-term safety and effectiveness of the drug olanzapine Zyprexa for reducing symptoms of autism in children
Detailed Description:
Autism is a serious childhood disorder that can significantly impair functioning and development Educational and psychosocial programs are standard treatments for autistic children but drug therapy is often needed as well Haloperidol is the drug most commonly prescribed for symptoms of autism However long-term administration of haloperidol has been associated with adverse effects such as blurred vision constipation and nausea The investigation of alternative drug treatments is necessary This study will determine whether the antipsychotic drug olanzapine may be a safe and effective alternative to haloperidol for treating symptoms of autism in children
This study will last 36 weeks and will comprise 2 phases In Phase I participants will be randomly assigned to receive either olanzapine or placebo for 12 weeks Participants who do not respond to treatment will complete their participation in the study Participants who respond to their assigned Phase I treatment will continue onto Phase II All Phase II participants will receive olanzapine daily for 6 months Self-report scales and checklists will be used to assess participants after each phase these measures will be completed by participants and their parents
This study will last 36 weeks and will comprise 2 phases In Phase I participants will be randomly assigned to receive either olanzapine or placebo for 12 weeks Participants who do not respond to treatment will complete their participation in the study Participants who respond to their assigned Phase I treatment will continue onto Phase II All Phase II participants will receive olanzapine daily for 6 months Self-report scales and checklists will be used to assess participants after each phase these measures will be completed by participants and their parents
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH073524 | NIH | None | None |
| DDTR B2-NDA | OTHER_GRANT | NIH | httpsreporternihgovquickSearchR01MH073524 |