CompletedPhase 2

Neurosteroids for PTSD in Veterans

United States96 participantsStarted 2019-05-01

Plain-language summary

This study seeks to determine if pregnenolone can improve symptoms of PTSD and other symptoms that commonly occur with PTSD in Iraq/Afghanistan-era Veterans. The total study duration is 10 weeks. Eligible Veterans with PTSD will receive either pregnenolone or placebo throughout the study duration and will complete mental and physical health assessments at each study visit. Eligible participants will attend 6 in-person study visits and receive several short "check-in" phone calls.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * DSM-5 diagnosis of PTSD with CAPS-5 Total Score 3 * Females will be required to use a medically and study approved contraceptive or otherwise not be of child-bearing potential * Birth control methods must be non-hormonal * No anticipated need to alter psychiatric medications for duration of study involvement * Ability to participate fully in the informed consent process Exclusion Criteria: * History of allergy to pregnenolone * Medical disorders that may preclude safe administration of pregnenolone or exacerbate PTSD symptoms * Current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern * Prior suicide attempt history or suicidal ideation that does not require clinical intervention or represent an imminent concern is permitted * Serious unstable medical illness, such as: * history of cerebrovascular accident * prostate * uterine or breast cancer * others (at the discretion of the PI and medical oversight team) * Medical conditions not well controlled will be excluded, at the discretion of the PI and Medical Team * Standard pharmacological interventions for PTSD will not be exclusionary, including, but not limited to: * antidepressant medications such as SSRIs, SNRIs, tricyclics, bupropion, mirtazapine, venlafaxine, and nefazodone * mood stabilizers such as carbamazepine, divalproex, lamotrigine, topiramate * atypical antipsychotics, and other agents including prazosin * However…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Through study completion, an average of 5 years

Trial details

NCT IDNCT03799562

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2025-07-07

View on ClinicalTrials.gov More Posttraumatic Stress Disorder trials