Actively Recruiting
A New Intervention to Improve Function in Veterans With Anxiety and Depression
Led by VA Office of Research and Development · Updated on 2026-04-23
84
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A New Intervention to Improve Function in Veterans With Anxiety and Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans enrolled for care at the Durham VAHCS
- Veterans who score a minimum score of 20 or higher (moderate symptoms) on the PHQ-ADS
- Women must use medically and study-approved non-hormonal contraception or be not of child-bearing potential
- No anticipated need to change psychiatric medications during the study
- Ability to fully participate in the informed consent process
You will not qualify if you...
- History of allergy to pregnenolone
- Medical conditions that prevent safe use of pregnenolone or worsen mental/physical symptoms
- PTSD diagnosis with PCL-5 score of 38 or higher
- Current suicidal or homicidal thoughts requiring clinical intervention or imminent concern
- Serious unstable medical illness such as stroke or certain cancers
- Changes in psychotropic medications within 4 weeks before randomization
- Current use of benzodiazepines or opioids
- Diagnosis of bipolar disorder, schizophrenia, psychotic disorder, or cognitive disorder due to medical condition other than mild TBI
- Psychotherapy started or changed within 3 months before randomization
- Pregnant or breast-feeding women
- Moderate or severe substance use disorders (except caffeine and tobacco) within 1 month before study entry
AI-Screening
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Trial Site Locations
Total: 1 location
1
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875
Actively Recruiting
Research Team
J
Jennifer C Naylor, PhD
CONTACT
C
Christine E Marx, MD MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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