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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Anxiety and depression are common and often occur together in Veterans, causing significant difficulties in daily function, work, and relationships. These conditions frequently come with poor sleep quality and chronic pain, which may share a biological cause. Researchers are studying pregnenolone, a medication that may help treat anxiety, depression, pain, and sleep problems all at once, with previous studies showing it is well tolerated by Veterans. This clinical trial is a 10-week, randomized, double-blind study comparing pregnenolone to a placebo in Veterans with anxiety and depression symptoms. The trial begins with a 2-week placebo-only lead-in, followed by 8 weeks of treatment where participants receive pregnenolone starting at 250 mg twice daily for 14 days, increasing to 500 mg twice daily for the next 14 days, and then 1000 mg twice daily for the remainder of the treatment period, or a matching placebo. The goal is to assess the impact of pregnenolone on functional impairment and symptoms. Participants will undergo assessments including questionnaires on disability, anxiety, depression, pain, and sleep quality at the start and end of the 10 weeks. Blood samples will be taken to measure neurosteroid levels and inflammatory markers. The main outcome is the change in disability scores after treatment. Safety and side effects will be monitored throughout the study, which is expected to end in 2028.
CONDITIONS
Brief 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 20 or higher on the PHQ-ADS indicating moderate symptoms
- Women must use medically and study-approved non-hormonal contraceptives if of child-bearing potential
- No anticipated need to change psychiatric medications during study
- Ability to give informed consent and participate fully
You will not qualify if you...
- Allergy to pregnenolone
- Medical conditions that prevent safe use of pregnenolone or worsen health symptoms
- PTSD diagnosis with PCL-5 score of 38 or higher
- Current suicidal or homicidal thoughts requiring clinical intervention
- Serious unstable medical illnesses such as stroke or certain cancers
- Use of benzodiazepines or opioids
- Diagnosis of bipolar disorder, schizophrenia, psychotic disorder, or cognitive disorder due to medical condition other than mild TBI
- Changes in psychotherapy within 3 months before study start
- Pregnant or breastfeeding women
- Moderate or severe substance use disorders (except caffeine and tobacco) within 1 month of study entry
- Changes in psychotropic medications within 4 weeks prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants undergo a 2-week placebo-only lead-in period before randomization.
Visits as scheduled during lead-in period
Duration - 8 weeks
Participants receive pregnenolone or placebo for 8 weeks with flexible dosing to improve function related to anxiety and depression.
Weekly visits for up to 8 weeks
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
C
Christine E Marx, MD MA
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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