A Study of Pregnenolone in the Treatment of Individuals With Autism
|ClinicalTrials.gov Identifier: NCT01881737|
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autistic Disorder||Drug: Pregnenolone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Pilot Study of Pregnenolone in the Treatment of Individuals With Autism|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Pregnenolone up to 500 mg per day
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.
- Number of Participants With Adverse Events According to Dosage Record and Treatment Emergent Symptom (DOTES) as Assessed at All Follow-up Visits (2, 4, 6, 8, 10, 12, and 16 Weeks) [ Time Frame: 2, 4, 6, 8, 10, 12, and 16 weeks ]
- Social Responsiveness Scale (SRS) Total Score [ Time Frame: 12 weeks ]SRS total score (total range 0-195); higher scores mean more abnormal social behaviors.
- Sensory Profile Questionnaire Total Score [ Time Frame: 12 ]scores on a scale (range: 38-190); lower scores mean more abnormal sensory problems.
- Vineland Adaptive Behavior Scale [ Time Frame: 12 weeks ]Adaptive Behavior Composite Score (score range 20-160); higher scores mean more typical adaptive behaviors.
- Repetitive Behavior Scale [ Time Frame: 12 weeks ]
- Pregnenolone Level in Peripheral Blood as Measured at Baseline and After 12 Weeks [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881737
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Antonio Hardan, MD||Stanford University|