Pregnenolone for Veterans with Anxiety and Depression

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

Recruiting Phase 2 Interventional Study
Anxiety and Depression
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for

This trial is looking for veterans who experience symptoms of anxiety and depression. Participants will take a medication called pregnenolone to see if it helps improve their symptoms and overall functioning.

Are You a Good Fit for This Trial?
Rules you out PregnancyBreastfeedingModerate or severe Substance Use Disorders

You may be able to join if

  • I am a veteran enrolled for care at the Durham VAHCS.
  • I have a score of 20 or higher on the PHQ-ADS.
  • I can use non-hormonal birth control or I am not capable of becoming pregnant.
  • I do not need changes to my psychiatric medications during the study.
  • I can fully participate in the informed consent process.

You may not be able to join if

  • I have a history of allergy to pregnenolone.
  • I have certain medical disorders that could make taking pregnenolone unsafe.
  • I have a PTSD diagnosis with a score of 38 or higher on the PCL-5.
  • I currently have thoughts of harming myself or others.
  • I have an unstable serious medical illness.
  • I use benzodiazepines or opioids.
  • I have a diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
  • I have had changes in psychotherapy in the last 3 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 unde…
Trial Locations
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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 …
Contacts

Jennifer C Naylor, PhD

(919) 286-0411

jennifer.naylor2@va.gov

CONTACT