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Pregnenolone for Anxiety and Depression in Veterans

This study is testing a drug called Pregnenolone to see if it can help improve daily function in Veterans experiencing anxiety and depression. These conditions can make it hard to work and maintain relationships. Researchers believe Pregnenolone might help with these symptoms, as well as with poor sleep and chronic pain, which often occur with anxiety and depression. You might be able to join if you are a Veteran aged 18 to 65, receive care at the Durham VAHCS, and have moderate to severe symptoms of anxiety and depression. The study will measure how much your daily function improves over 10 weeks. The current status of this study is unclear.

Study design
This interventional study plans to enroll 84 participants. Participants will receive either Pregnenolone or a placebo (an inactive substance) in a structured way.
What's involved
Participants will take Pregnenolone or a placebo daily, with the dose of Pregnenolone increasing over the first 28 days, for a total of 8 weeks. Your daily function will be assessed at 10 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary measure of success is taken at 10 weeks after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06188923

A New Intervention to Improve Function in Veterans With Anxiety and Depression

Recruiting
PHASE2Ages 18–65InterventionalTreatment
VA Office of Research and Development
~84 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:PregnenolonePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The World Health Organization disability assessment schedule II (WHODAS-2)
Measured over Change from baseline at 10 weeks

Conditions

Anxiety and Depression

Explore related trials

AnxietyDepression

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Jennifer C Naylor, PhD · PRINCIPAL_INVESTIGATOR · Durham VA Medical Center, Durham, NC
  • Christine E. Marx, MD MA · PRINCIPAL_INVESTIGATOR · Durham VA Medical Center, Durham, NC

Who to contact

Jennifer C Naylor, PhD
[email protected]
(919) 286-0411 · ext. 7722
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • The World Health Organization disability assessment schedule II (WHODAS-2)Change from baseline at 10 weeks

    The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning of the individual in six activity domains (i.e., understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society). The 12-item WHODAS 2.0 score range from 12 to 60, where higher scores indicate higher disability or loss of function.