Ignite Creation Date:
2024-05-05 @ 9:24 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00873509
Status:
COMPLETED
Last Update Posted:
2016-07-26
First Post:
2009-03-30
Brief Title:
Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder
Sponsor:
Chugani Diane C
Organization:
Chugani Diane C
Study Overview
Official Title:
A Randomized Placebo-controlled Double-masked Clinical Trial of Buspirone in the Treatment of 2- 6 Year Old Children With Autistic Disorder
Status:
COMPLETED
Status Verified Date:
2016-07
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:
B-ACE
Brief Summary:
The purpose of this study is to evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children aged 2-6 years as measured by the change from baseline in the Autism Diagnostic Observation Schedule ADOS Composite Total scores compared to placebo at 6 months
Detailed Description:
This is a multi-center randomized placebo-controlled double-masked study of 166 evaluable participants taking buspirone twice daily for 6 months Children aged 2-6 years with autism will be randomized to receive one of three treatments 25mg 50mg or matched placebo The placebo controlled trial will be followed by an optional follow-up trial to assess the long term safety of buspirone In addition a PET scan of serotonin synthesis and plasma serotonin will be measured at baseline to determine whether these measures are predictors of drug response This trial is aimed at the core features of autism The outcome measures for efficacy will be examiner and parent ratings on psychological tests and questionnaires The outcome measure for the primary objective will be the Autism Diagnostic Observation Scale ADOS Composite Total score The behavioral outcomes for the secondary aims are delineated in the study design
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 |
|---|---|---|---|
| 5U01NS061264 | NIH | None | httpsreporternihgovquickSearch5U01NS061264 |