A Study of Pregnenolone in the Treatment of Individuals With Autism

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
Autistic Disorder
Interventions
DRUG

Pregnenolone

"With Baseline serving as approximately day 1, twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg~Week 3 and 4: 200 mg~Week 5 and 6: 300 mg~Week 7 and 8: 400 mg~Week 9 -12: 500 mg~At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."

Trial Locations (1)

94305

Stanford University School of Medicine, Stanford

All Listed Sponsors
lead

Stanford University

OTHER

NCT01881737 - A Study of Pregnenolone in the Treatment of Individuals With Autism | Biotech Hunter | Biotech Hunter