A Study of Pregnenolone in the Treatment of Individuals With Autism

Inclusion Criteria:

   1. Outpatients 18-45 years of age;

   2. Males and females who are physically healthy;

   3. Diagnosis of autism based on Diagnostic and Statistical Manual (DSM-IV-TR) criteria,
   the Autism Diagnostic Interview-Revised, and expert clinical evaluation;

   4. Total Aberrant Behavior Checklist (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.

Exclusion Criteria:

   1. Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of schizophrenia,
   schizoaffective disorder, or psychotic disorder, not otherwise specified;

   2. Prior adequate trial of pregnenolone;

   3. Active medical problems: unstable seizures, significant physical illness (e.g.,
   serious liver or renal pathology);

   4. Pregnancy or sexually active females (as determined by a urinary pregnancy test in the
   beginning of the study); and

   5. Subjects taking oil or fat based nutritional supplements will be excluded from the
   study unless they have been off these compounds for at least 4 weeks