Could a natural hormone ease anxiety and depression in veterans?
NCT ID NCT06188923
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study tests whether a natural hormone called pregnenolone can improve daily functioning in veterans with anxiety and depression. 84 veterans will take either pregnenolone or a placebo for 8 weeks. The goal is to see if it helps with mood, sleep, and pain, with minimal side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pregnenolone
- What this could lead to
- If it works, this could point toward a new treatment option for veterans struggling with anxiety, depression, poor sleep, and chronic pain.
- What could go wrong
- This is an early Phase 2 trial with only 84 participants, so results may not apply to everyone. The drug may not improve function or symptoms as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Veterans enrolled for care at the Durham VAHCS * Veterans who score a minimum score of 20 or higher (moderate symptoms) on the PHQ-ADS (Kroenke et al 2017) * Oral pregnenolone could reduce the effectiveness of oral contraceptives, thus women 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 PREG * Medical disorders that may preclude safe administration of PREG or exacerbate mental or physical health symptoms * PTSD diagnosis, as per the PCL-5, scores of 38 or higher * Current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern * Prior attempts 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) * Standard pharmacological interventions for mental health disorders will not be exclusionary; however, there may be no changes in psychotropic medications for mental or physical health conditions 4 weeks prior to study randomization * Benzodiazepine or opioid use * Current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than mild TBI (assessed at screening) * Initiation or change in psychotherapy within 3 months of randomization (i.e., psychotherapy must be stable for 3 months prior to study start * Due to lack of safety data in pregnant and breast-feeding women, female participants who are pregnant or breast-feeding will be excluded * As indicated by the DSM-5, moderate or severe Substance Use Disorders (excluding caffeine and tobacco) within 1 month of study entry
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Durham VA Medical Center, Durham, NC
RECRUITINGDurham, North Carolina, 27705-3875, United States
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