Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211757
Status:
COMPLETED
Last Update Posted:
2018-12-06
First Post:
2005-09-13
Brief Title:
Divalproex Sodium vs Placebo in ChildhoodAdolescent Autism
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Divalproex Sodium vs Placebo in ChildhoodAdolescent Autism
Status:
COMPLETED
Status Verified Date:
2018-12
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 study is designed to assess the efficacy of treatment with divalproex sodium DS vs placebo in childhoodadolescent autism fulfilling DSM-IV and Autism Diagnostic Interview ADI criteria Currently there are no FDA-approved treatments for this disorder although behavioral and educational therapies and a variety of medications may play a role in the management of some autistic symptoms
Detailed Description:
This study compares divalproex sodium and placebo in the treatment of autistic disorder Twenty six child or adolescent outpatients with age ranges from 5-17 will be randomized into a 12-week double-blind placebo-controlled parallel treatment study During the 12 weeks patients will be monitored by the treating psychiatrist and assessed by an independent evaluator IE The IE will perform study assessments while remaining blind to medication regimens including possible tapering as well as any side effects Study assessments will be administered at designated time points
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 |
|---|---|---|---|
| 1R21NS043979 | NIH | None | httpsreporternihgovquickSearch1R21NS043979 |