Status:
RECRUITING
A New Intervention to Improve Function in Veterans With Anxiety and Depression
Lead Sponsor:
VA Office of Research and Development
Conditions:
Anxiety and Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 relation...
Detailed Description
Background: Anxiety and depression disorders can be very debilitating and result in substantial disability. These disorders are extremely common, occurring at rates that exceed other common medical il...
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
Key Trial Info
Start Date :
August 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06188923
Start Date
August 14 2025
End Date
September 30 2028
Last Update
August 20 2025
Active Locations (1)
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1
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875