A 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.

Pregnenolone has been used safely in research studies involving individuals with
schizophrenia. In the proposed trial, we hope to examine the tolerability of pregnenolone in
adults with autism. We hope to see improvement in behavioral outcomes as measured by
standardized behavioral measures. Further, we will measure concentrations of pregnenolone
and related neuroactive compounds in the blood. The use of pregnenolone has been studied in
a number of mental disorders but not autism. Thus, we hope the study will identify new
avenues of research for the treatment of autism.

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.

Exclusion Criteria:

1. DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder
NOS;

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