An Open-Label Pilot Study of Pregnenolone in the Treatment of Individuals With Autism

This study will assess the tolerability and effectiveness of pregnenolone in the treatment of behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone found in the body which has been shown to help with the function of nerve cells. It is also shown to modulate the activity of certain brain receptors implicated in autism. We hope to examine the tolerability of pregnenolone in adults with autism.

Stanford is now accepting new patients for this trial. Please contact Robin Libove, BS at 650-736-1235 for more information.



  • drug : Pregnenolone

Phase: Phase 2


Ages Eligible For Study:

18 Years - 45 Years

Inclusion Criteria

1. Outpatients 18-45 years of age; 2. Males and females who are physically healthy; 3. Diagnosis of autism based on DSM-IV-TR criteria, the Autism Diagnostic Interview-Revised, and expert clinical evaluation; 4. Total ABC greater then 21; 5. Care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis; 6. Ability of subject to swallow the compound; 7. Stable concomitant medications for at least 2 weeks; and 8. No planned changes in psychosocial interventions during the open-label pregnenolone trial.

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Contact information

Primary Contact:

Robin Libove, BS 650-736-1235

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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