RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: VA Office of Research and Development • ClinicalTrials.gov ID: NCT06188923

Registry updated: 2026-10-14

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Description

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.

Interventions

Pregnenolone (Drug)
Pregnenolone 250 milligrams (mg) BID x 14 DAYS, followed by Pregnenolone 500 milligrams (mg) BID x 14 DAYS, followed by Pregnenolone 1000 milligrams (mg) BID x thereafter for the remainder of the 8-week trial.
Placebo (Drug)
Same as active comparator, except placebo dispensed

Eligibility criteria

Inclusion Criteria: 1. Veterans enrolled for care at the Durham Veterans Affairs Health Care System (VAHCS) 2. Veterans who score a minimum score of 20 or higher (moderate symptoms) on the PHQ-ADS (Kroenke et al 2017) 3. 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. 4. No anticipated need to alter psychiatric medications for duration of study involvement 5. Ability to participate fully in the informed consent process Exclusion Criteria: 1. History of allergy to pregnenolone (PREG) 2. Medical disorders that may preclude safe administration of PREG or exacerbate mental or physical health symptoms 3. Post-traumatic stress disorder (PTSD) diagnosis, as per the PCL-5 with LEC-5, scores of 38 or higher 4. 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 5. 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) 6. 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 7. Benzodiazepine or opioid use 8. 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) 9. Initiation or change in psychotherapy within 3 months of randomization (i.e., psychotherapy must be stable for 3 months prior to study start 10. Due to lack of safety data in pregnant and breast-feeding women, female participants who are pregnant or breast-feeding will be excluded 11. As indicated by the DSM-5, moderate or severe Substance Use Disorders (excluding caffeine and tobacco) within 1 month of study entry

Conditions

Anxiety and Depression

Locations

Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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