Status:
COMPLETED
A Study of Pregnenolone in the Treatment of Individuals With Autism
Lead Sponsor:
Stanford University
Conditions:
Autistic Disorder
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Outpatients 18-45 years of age;
- Males and females who are physically healthy;
- Diagnosis of autism based on Diagnostic and Statistical Manual (DSM-IV-TR) criteria, the Autism Diagnostic Interview-Revised, and expert clinical evaluation;
- Total Aberrant Behavior Checklist (ABC) greater then 21;
- Care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis;
- Ability of subject to swallow the compound;
- Stable concomitant medications for at least 2 weeks; and
- No planned changes in psychosocial interventions during the open-label pregnenolone trial.
Exclusion
- Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder, not otherwise specified;
- Prior adequate trial of pregnenolone;
- Active medical problems: unstable seizures, significant physical illness (e.g., serious liver or renal pathology);
- Pregnancy or sexually active females (as determined by a urinary pregnancy test in the beginning of the study); and
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01881737
Start Date
July 1 2011
End Date
September 1 2013
Last Update
March 29 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305