RecruitingPhase 2NCT06188923

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


Sponsor

VA Office of Research and Development

Enrollment

84 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Anxiety and depression symptoms occur at high rates in Veteran populations and can significantly impact function, compromising the ability to work and to successfully form and maintain valued relationships. Several other symptoms commonly occur with anxiety and depression, including poor sleep quality and chronic pain. Since all these symptoms frequently occur together, they may have a common underlying biological basis. A single medication that could effectively treat all these symptoms would be ideal. Converging data suggest that pregnenolone is a promising pharmacological agent for treating multiple psychiatric symptoms and functional impairment. The investigators thus propose to conduct a clinical trial of pregnenolone in Veterans with anxiety and depression symptoms. Pregnenolone has minimal side effects, and the prior research demonstrates that pregnenolone is well-tolerated by Veterans. Treatment with pregnenolone could thus be an efficacious new therapeutic for Veterans experiencing depression, anxiety, poor sleep quality and chronic pain conditions.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new behavioral intervention (combined with pregnenolone, a naturally occurring hormone) to improve daily functioning in US military veterans who are experiencing moderate to severe anxiety and depression. **You may be eligible if...** - You are a veteran enrolled in care at the Durham VA Health Care System - You score 20 or higher on the PHQ-ADS depression and anxiety screening tool (indicating moderate symptoms) - You are willing to use a medically approved form of contraception if you are a woman of childbearing potential (because pregnenolone may reduce the effectiveness of oral contraceptives) **You may NOT be eligible if...** - You are not enrolled at the Durham VAHCS - You have a serious medical condition that the study team believes would interfere with safe participation - You are pregnant or trying to become pregnant - You have a current substance use disorder that is the primary concern Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPregnenolone

Pregnenolone 250 mg BID x 14 DAYS, followed by Pregnenolone 500 mg BID x 14 DAYS, followed by Pregnenolone 1000 mg BID x thereafter for the remainder of the 8-week trial.

DRUGPlacebo

Same as active comparator, except placebo dispensed


Locations(1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT06188923


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