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Pregnenolone for Autism
Study Summary
This trial is testing whether the hormone pregnenolone is effective and safe for treating symptoms of autism. The goal is to improve social communication and reduce irritability and sensitivity to sensory differences.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2011 Phase 4 trial • 80 Patients • NCT01409096Trial Design
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Who is running the clinical trial?
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- I am not pregnant or I use birth control if sexually active.I am between 14 and 25 years old and have reached a late stage of puberty.I am physically healthy.My medications have not changed in the last 2 weeks.My medications have not changed in the last 2 weeks.I am currently taking steroid medications.OR
Aberrant Behavior Checklist-Irritability (ABC-I)≥ 15 and Clinical Global Impression-Severity subscale (CGI-S) ≥4
The person has a lot of problems with irritability and their Global Impression of Severity is at least a 4 out of 7.You have already tried the medication pregnenolone in the past.You cannot make any changes to your mental health treatment plan during the trial.I do not have frequent seizures or severe illness.I am physically healthy.I am between 14 and 25 years old and have reached a late stage of puberty.You cannot change your current counseling or therapy during the trial.
- Group 1: Pregnenolone (up to 500 mg per day)
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To what degree is Pregnenolone hazardous to those receiving it?
"Due to the Phase 2 status of this trial, which signals a lack of efficacy data but some safety information, our team has assigned Pregnenolone a score of 2."
Are there still vacancies available in this research project?
"Affirmative. Clinicaltrials.gov provides evidence that this medical trial is recruiting patients, having been first published on January 29th 2016 and updated February 15 2022. 40 participants are needed at a single medical facility to complete the study."
Does this medical trial permit participation from individuals younger than 55?
"To qualify for the research, patients must be between 14 and 25 years old. There are 235 studies dedicated to those under 18 and 51 devoted to elderly individuals above 65."
What is the upper boundary of participants in this experiment?
"Affirmative. Clinicaltrials.gov confirms that this research project, which was initially posted on January 29th 2016, is actively recruiting participants. The investigators are seeking 40 volunteers from a solitary medical site."
Is Pregnenolone being studied in any other research projects?
"At present, 6 clinical trials are underway to explore the efficacy of Pregnenolone. Unfortunately, none have reached Phase 3 yet. Nevertheless, there are 7 sites across Dallas, Texas that are conducting experiments with this medication."
What are the eligibility criteria for enrolling in this research?
"This trial is recruiting 40 adolescents and young adults with autism, between the ages of 14-25. To qualify, participants must have been taking stable medications for at least two weeks; display male/female physical health; demonstrate a Tanner stage IV or V level maturity; present an Aberrant Behavior Checklist Irritability score of 18+ and Clinical Global Impression Severity subscale ≥ 4; and not plan to alter any psychosocial interventions during study duration."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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