Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT02627508
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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
25 Years
Study:
NCT02627508
Study Brief:
Protocol Section:
NCT02627508