Clinical Trial: A Study of Pregnenolone in the Treatment of Individuals With Autism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label Pilot Study of Pregnenolone in the Treatment of Individuals With Autism

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 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. We hope to examine the tolerability of pregnenolone in adults with autism.

Detailed 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 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.


Sponsor: Stanford University

Current Primary Outcome: 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 ]

Original Primary Outcome: 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 ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Social Responsiveness Scale [ Time Frame: 12 and 16 weeks ]
  • Sensory Profile Questionnaire [ Time Frame: 12 and 16 weeks ]
  • Vineland Adaptive Behavior Scale [ Time Frame: 12 and 16 weeks ]
  • Repetitive Behavior Scale [ Time Frame: 12 and 16 weeks ]
  • Levels of pregnenolone and its related neurosteroids in peripheral blood [ Time Frame: 12 weeks ]


Information By: Stanford University

Dates:
Date Received: November 28, 2011
Date Started: July 2011
Date Completion:
Last Updated: February 8, 2017
Last Verified: February 2017