Phase 2 Depression and Anxiety Trial, Recruiting NCT06188923 Sponsor: VA Office of Research and Development Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT06188923
Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who are Veterans receiving care at the Durham VA Health Care System
  • People who score 20 or higher on a combined depression and anxiety questionnaire called the PHQ-ADS, which indicates moderate symptoms
  • Women who are able to become pregnant must use a non-hormonal birth control method that is approved by the study team for the duration of the trial
  • People whose psychiatric medications are not expected to need any changes during the study period
  • People who are able to fully take part in the informed consent process

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have had an allergic reaction to pregnenolone in the past
  • People with certain medical conditions that could make taking pregnenolone unsafe or that could worsen their mental or physical health symptoms
  • People who have a PTSD diagnosis and score 38 or higher on a standard PTSD symptom checklist (called the PCL-5)
  • People who are currently having thoughts of harming themselves or others that require immediate clinical attention
  • People with certain serious or unstable medical conditions, such as a history of stroke, or prostate, uterine, or breast cancer — the study's medical team makes the final decision on this
  • People who have changed or started a psychiatric medication within 4 weeks before the study begins
  • People who currently use benzodiazepines (a type of sedative/anxiety medication) or opioids
  • People who currently have a diagnosis of bipolar disorder, schizophrenia, another psychotic disorder, or a cognitive disorder caused by a medical condition (other than mild traumatic brain injury)
  • People who have started or changed a psychotherapy program within 3 months before the study begins — any psychotherapy must have been stable for at least 3 months
  • Women who are currently pregnant or breastfeeding
  • People who have had a moderate or severe substance use disorder (not including caffeine or tobacco) within 1 month of entering the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 July 2026

Contact this trial

Principal Investigator: Jennifer C Naylor, PhD, Durham VA Medical Center, Durham, NC

Phone: (919) 286-0411

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
14 August 2025
Est. completion
30 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The World Health Organization disability assessment schedule II (WHODAS-2)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov