← Back to Search

Neurosteroid

Pregnenolone for PTSD

Phase 2

Recruiting

Led By Jennifer C Naylor, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No anticipated need to alter psychiatric medications for duration of study involvement

Females will be required to use a medically and study approved contraceptive or otherwise not be of child-bearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 5 years

Awards & highlights

Study Summary

This trial will test whether the drug pregnenolone can help improve symptoms of PTSD and other co-occurring symptoms in veterans of the Iraq and Afghanistan wars. Veterans will be randomly assigned to receive either the drug or a placebo, and they will be assessed at regular intervals over the course of ten weeks.

Who is the study for?

This trial is for Iraq/Afghanistan-era Veterans with PTSD who can commit to a 10-week study without changing their psychiatric medications. They must not have severe medical conditions, be pregnant or breastfeeding, use hormonal therapies, or have substance abuse issues. Stable non-hormonal birth control is required for women.Check my eligibility

What is being tested?

The study tests if pregnenolone improves PTSD symptoms compared to a placebo over 10 weeks. Participants will receive either the hormone or placebo and undergo regular health assessments during six in-person visits and check-in calls.See study design

What are the potential side effects?

While specific side effects are not listed, pregnenolone may cause hormonal changes that could affect mood and physical health. Allergic reactions are possible, as well as potential exacerbation of PTSD symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I don't expect to change my psychiatric meds during the study.

Select...

I am using approved birth control or cannot become pregnant.

Select...

I understand and can participate in the consent process.

Select...

I have been diagnosed with PTSD and my CAPS-5 score is at least 3.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Clinician Administered PTSD Scale for DSM-5 (Visit 6-Baseline)

Secondary outcome measures

Change in Brief Pain Inventory, Short Form (Visit 6-Baseline)

Change in Hamilton-Depression Inventory (Visit 6-Baseline)

Side effects data

From 2011 Phase 4 trial • 80 Patients • NCT01409096

Sinusitis

Corneal ulceration

Skin abscess followed by allergic reaction to antibiotic used to treat it

Skin rash

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Pregnenolone

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PregnenoloneExperimental Treatment1 Intervention

Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial

Group II: PlaceboPlacebo Group1 Intervention

Same as pregnenolone (active study medication), except placebo dispensed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pregnenolone

2011

Completed Phase 4

~770

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,513 Total Patients Enrolled

Jennifer C Naylor, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC

2 Previous Clinical Trials

192 Total Patients Enrolled

Media Library

Pregnenolone (Neurosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03799562 — Phase 2

Post-Traumatic Stress Disorder Research Study Groups: Pregnenolone, Placebo

Post-Traumatic Stress Disorder Clinical Trial 2023: Pregnenolone Highlights & Side Effects. Trial Name: NCT03799562 — Phase 2

Pregnenolone (Neurosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03799562 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other scientific investigations have included Pregnenolone as a variable?

"Currently, there are six ongoing studies investigating the use of pregnenolone. None of those studies are in phase 3. Although many of the trials for this medication are based in Dallas, Texas, there are seven locations running these studies."

Answered by AI

Could you please share how many people are participating in this trial?

"The information on clinicaltrials.gov does show that this trial is looking for participants. It was originally posted on May 1st, 2019 and the last edit was on January 6th, 2022. They are hoping to find 90 individuals total from one site."

Answered by AI

What are some of the risks associated with Pregnenolone?

"Pregnenolone's safety is based on some data collected from Phase 2 trials. However, as this drug has not yet reached Phase 3 testing, there is no efficacy data available."

Answered by AI

Could I possibly be a candidate for this test?

"This trial is only for patients that have post traumatic stress disorder and are between the ages of 18-65. Out of the 90 total participants, there are still some available slots."

Answered by AI

Will adults of a certain age still be able to experience the benefits of this proposed treatment?

"In order to participate in this particular clinical trial, applicants must be aged between 18 and 65 years old. There are 47 other trials for people who are under the age of 18 and 339 for those over the age of 65."

Answered by AI

Are there any current vacancies for this clinical trial?

"Per the information available on clinicaltrials.gov, this study is still enrolling patients and recruiting from 1 site. The first posting was on May 1st, 2019 with the most recent update being January 6th, 2022. They are looking for a total of 90 individuals to complete the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neurosteroids for PTSD in Veterans

2019. "Neurosteroids for PTSD in Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03799562.

All > Ptsd High Point > Ptsd