Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-01 @ 8:57 PM
Study NCT ID:
NCT02627508
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2015-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Trial of Pregnenolone in Autism
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Randomized Controlled Pilot Trial of Pregnenolone in Autism
Status:
RECRUITING
Status Verified Date:
2025-02
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 research study to examine the tolerability and effectiveness of pregnenolone in individuals with autism. Pregnenolone is a naturally occurring steroid hormone in the brain that has been implicated in treating various psychiatric conditions. The investigators hope to learn the effects and safety of using pregnenolone in reducing irritability and sensitivity to sensory differences and improving social communication in individuals with autism. The investigators hope by studying the effects of pregnenolone in more detail, the investigators can design better ways to treat individuals with autism.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: