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

Conditions

• Anxiety and Depression

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Aug 14, 2025

Status verified

Apr 2026

Primary completion

Jun 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

84 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Pregnenolone
  Pregnenolone 250 mg BID x 14 DAYS, followed by Pregnenolone 500 mg BID x 14 DAYS, followed by Pregnenolone 1000 mg BID x thereafter for the remainder of the 8-week trial.
• Placebo Comparator: Placebo
  Same as active comparator, except placebo dispensed

Primary Outcome Measure

The World Health Organization disability assessment schedule II (WHODAS-2) [ Time Frame: Change from baseline at 10 weeks ]

Central Contacts

• Jennifer C Naylor, PhD
  (919) 286-0411
  [email protected]
• Christine E Marx, MD MA
  (919) 286-0411
  [email protected]

Locations (1)

Find similar trials in Durham, NC