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 trustworthyratings, 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 pregnenolonetrial.

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 thebeginning of the study); and

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