Autistic Disorder Clinical Trial
Official title:
An Open-Label Pilot Study of Pregnenolone in the Treatment of Individuals With Autism
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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