Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Randomized Controlled Pilot Trial of Pregnenolone in Autism

ID
Name
IRB-34762
Description
This is a research study to examine the tolerability and effectiveness of pregnenolone in individuals with autism. Pregnenolone is a naturally occurring steroid hormone in the brain that has been implicated in treating various psychiatric conditions. The investigators hope to learn the effects and safety of using pregnenolone in reducing irritability and sensitivity to sensory differences and improving social communication in individuals with autism. The investigators hope by studying the effects of pregnenolone in more detail, the investigators can design better ways to treat individuals with autism.
Trial arms
Trial start
2016-01-29
Estimated PCD
2025-03-01
Trial end
2025-03-01
Status
Recruiting
Phase
Early phase I
Treatment
Pregnenolone
orally administered Pregnenolone capsules
Arms:
Pregnenolone (up to 500 mg per day)
Placebo
orally administered placebo capsules
Arms:
Placebo
Size
40
Primary endpoint
Change from baseline in parent rated Aberrant Behavior Checklist Irritability (ABC-I) score during treatment
2-week, 4-week, 6-week, 8-week, 10-week, 14-week
Eligibility criteria
Inclusion Criteria: * outpatients between 14 and 25 years of age with a Tanner stage of IV or V; * male and female subjects who were physically healthy; * diagnosis of ASD based on DSM-5, expert clinical opinion and confirmed with Autism Diagnostic Interview - Revised (ADI-R) and either Autism Diagnostic Observation Schedule (ADOS) or Childhood Autism Rating Scale (CARS-2); * Aberrant Behavior Checklist -Irritability (ABC-I)≥ 18 and Clinical Global Impression (CGI)-Severity subscale ≥ 4; * stable concomitant medications for at least 2 weeks; * no planned changes in psychosocial interventions during the trial. Exclusion Criteria: * Diagnostic and Statistical Manual (DSM-5) diagnosis of schizophrenia, schizoaffective disorder, alcohol use disorder; * prior adequate trial of pregnenolone; * active medical problems: unstable seizures (\>2 in past month), significant physical illness; * pregnant or sexually active female subjects who do not adhere to use an appropriate form of external prophylactics; * participants taking steroid medications.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-07-14

1 organization

1 product

1 drug

2 indications

Organization
Stanford University
Product
Pregnenolone
Indication
Autism Spectrum Disorder
Indication
Autism
Drug
Varlilumab