ACTIVE_NOT_RECRUITING

Pilot Trial of Pregnenolone in Autism

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Randomized Controlled Pilot Trial of Pregnenolone in Autism

Quick Facts

Study Start:2016-01-29
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT02627508

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * outpatients between 14 and 25 years of age with a Tanner stage of IV or V;
  2. * male and female subjects who were physically healthy;
  3. * 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);
  4. * Aberrant Behavior Checklist -Irritability (ABC-I)≥ 18 and Clinical Global Impression (CGI)-Severity subscale ≥ 4;
  5. * stable concomitant medications for at least 2 weeks;
  6. * no planned changes in psychosocial interventions during the trial.
  1. * Diagnostic and Statistical Manual (DSM-5) diagnosis of schizophrenia, schizoaffective disorder, alcohol use disorder;
  2. * prior adequate trial of pregnenolone;
  3. * active medical problems: unstable seizures (\>2 in past month), significant physical illness;
  4. * pregnant or sexually active female subjects who do not adhere to use an appropriate form of external prophylactics;
  5. * participants taking steroid medications.

Contacts and Locations

Principal Investigator

Antonio Y. Hardan, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University School of Medicine
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Antonio Y. Hardan, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-01-29
Study Completion Date2026-05

Study Record Updates

Study Start Date2016-01-29
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Autism Spectrum Disorder
  • Autism
  • Pregnenolone

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Autism