Autism, Autism Spectrum Disorder
Conditions
Keywords
Autism Spectrum Disorder, Autism, Pregnenolone
Brief summary
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.
Interventions
DRUGPregnenolone
orally administered Pregnenolone capsules
DRUGPlacebo
orally administered placebo capsules
Sponsors
Stanford University
Simons Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 25 Years
Healthy volunteers
No
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 Autism Spectrum Disorder (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in parent rated Aberrant Behavior Checklist (ABC) scores during treatment | 2-week, 4-week, 6-week, 8-week, 10-week, 14-week |
| Change from baseline in parent rated Sensory Profile Questionnaire (SPQ) scores during treatment | 2-week, 4-week, 6-week, 8-week, 10-week, 14-week |
| Change from baseline in Vineland Adaptive Behavior Scales Second Edition (VABS-II) | 2-week, 6-week, 10-week, 14-week |
| Change from baseline in Clinical Global Impression (CGI) scores during treatment | 2-week, 4-week, 6-week, 8-week, 10-week, 14-week |
| Change from baseline in levels of pregnenolone and its related neurosteroids in peripheral blood | 14-week |
| Change from baseline on the Autism Diagnostic Observation Schedule (ADOS) | 14-week |
| Change from baseline in laboratory based eye-gaze measures | 14-week |
| Change from baseline in laboratory based electroencephalography (EEG) measures | 14-week |
| Change from baseline in laboratory clinical lab values including complete metabolic panel, complete blood count with differential, cholesterol panel and routine urinalysis. | 14-week |
| Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment | 2-week, 6-week, 10-week, 14-week |
| Change from baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) scores during treatment | 2-week, 4-week, 6-week, 8-week, 10-week, 14-week |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAntonio Y. Hardan, MD
Stanford University
Outcome results
None listed