NCT02627508

Pilot Trial of Pregnenolone in Autism

Randomized Controlled Pilot Trial of Pregnenolone in Autism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 14 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder
• Autism

Interventions

Type	Name	Description
DRUG	Pregnenolone	orally administered Pregnenolone capsules
DRUG	Placebo	orally administered placebo capsules

Timeline

• Start date: 2016-01-29
• Primary completion: 2026-03-13
• Completion: 2026-03-17
• First posted: 2015-12-11
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States