A Study of Pregnenolone in the Treatment of Individuals With Autism
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Pilot Study of Pregnenolone in the Treatment of Individuals With Autism|
- Change from Baseline in Dosage Record and Treatment Emergent Symptom (DOTES) at 2, 4, 6, 8, 10, 12, and 16 weeks [ Time Frame: Baseline, 2, 4, 6, 8, 10, 12, and 16 weeks ] [ Designated as safety issue: Yes ]
- Social Responsiveness Scale [ Time Frame: 12 and 16 weeks ] [ Designated as safety issue: No ]
- Sensory Profile Questionnaire [ Time Frame: 12 and 16 weeks ] [ Designated as safety issue: No ]
- Vineland Adaptive Behavior Scale [ Time Frame: 12 and 16 weeks ] [ Designated as safety issue: No ]
- Repetitive Behavior Scale [ Time Frame: 12 and 16 weeks ] [ Designated as safety issue: No ]
- Levels of pregnenolone and its related neurosteroids in peripheral blood [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
pregnenolone up to 500 mg/d
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.
Days 1-14: 100 mg
Week 1 and 2: 200 mg
Week 3 and 4: 350 mg
Week 5 and 6: 400 mg
Week 7 -12: 500 mg
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01881737
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Antonio Hardan, MD||Stanford University|