RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-08-14
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06188923

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veterans enrolled for care at the Durham 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
  1. * History of allergy to PREG
  2. * Medical disorders that may preclude safe administration of PREG or exacerbate mental or physical health symptoms
  3. * PTSD diagnosis, as per the PCL-5, scores of 38 or higher
  4. * Current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern
  5. * Prior attempts or suicidal ideation that does not require clinical intervention or represent an imminent concern is permitted
  6. * 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)
  7. * 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
  8. * Benzodiazepine or opioid use
  9. * 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)
  10. * Initiation or change in psychotherapy within 3 months of randomization (i.e., psychotherapy must be stable for 3 months prior to study start
  11. * Due to lack of safety data in pregnant and breast-feeding women, female participants who are pregnant or breast-feeding will be excluded
  12. * As indicated by the DSM-5, moderate or severe Substance Use Disorders (excluding caffeine and tobacco) within 1 month of study entry

Contacts and Locations

Study Contact

Jennifer C Naylor, PhD
CONTACT
(919) 286-0411
jennifer.naylor2@va.gov
Christine E Marx, MD MA
CONTACT
(919) 286-0411
christine.marx@va.gov

Principal Investigator

Jennifer C Naylor, PhD
PRINCIPAL_INVESTIGATOR
Durham VA Medical Center, Durham, NC
Christine E. Marx, MD MA
PRINCIPAL_INVESTIGATOR
Durham VA Medical Center, Durham, NC

Study Locations (Sites)

Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jennifer C Naylor, PhD, PRINCIPAL_INVESTIGATOR, Durham VA Medical Center, Durham, NC
  • Christine E. Marx, MD MA, PRINCIPAL_INVESTIGATOR, Durham VA Medical Center, Durham, NC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-14
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2025-08-14
Study Completion Date2028-09-30

Terms related to this study

Keywords Provided by Researchers

  • pregnenolone
  • anxiety
  • depression
  • pain
  • sleep

Additional Relevant MeSH Terms

  • Anxiety and Depression