Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211796
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2005-09-13
Brief Title:
Divalproex Sodium ER in Adult Autism
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Divalproex Sodium ER in Adult Autism
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
12-week open label treatment trial of divalproex sodium extended release Depakote ER in 10 patients with a diagnosis of autism Our objective is to determine how well these patients can tolerate the prescribed doses and what added benefits can be attributed to divalproex sodium ER
Detailed Description:
Based on positive research with divalproex in childrenadolescents with autism we would like to extend this research to autistic adults with high levels of aggression irritability affective instability or agitation We aim to have 10 adult autistic patients enrolled in our study of the treatment of aggressionirritability with divalproex sodium ER This will be an open treatment for adult patients to determine if the tolerability of divalproex sodium is better with the extended release We propose this open label design because previous double-blinded studies of divalproex sodium were only done in children not adults These results will serve as pilot data for a future blinded study for autistic adults with the extended release formulation This naturalistic design will allow for prior stable 3 months use of concomitant medications Our objective is to determine how well these patients can tolerate the prescribed doses and what added benefits can be attributed to divalproex sodium ER
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