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.
- drug : Pregnenolone
Phase: Phase 2
Ages Eligible For Study:
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.