Pregnenolone for Anxiety and Depression

Overseen by Christine E Marx, MD MA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: VA Office of Research and Development

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of 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 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.

Research Team

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

Eligibility Criteria

This trial is for veterans experiencing symptoms of anxiety and depression, who may also be dealing with poor sleep quality and chronic pain. To participate, they should not have any conditions that would exclude them from the study as per the trial's specific criteria.

Inclusion Criteria

I am using or will use a non-hormonal birth control method or cannot become pregnant.

I don't expect to change my psychiatric meds during the study.

Veterans enrolled for care at the Durham VAHCS

Exclusion Criteria

I do not have a serious illness like a stroke or cancer (prostate, uterine, breast) that is currently unstable.

Current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern

I don't have health issues that would make taking PREG unsafe.

Treatment Details

Interventions

• Pregnenolone (Corticosteroid)

Trial Overview The clinical trial is testing pregnenolone, a medication thought to help with psychiatric symptoms and improve overall function in those suffering from anxiety and depression. Participants will either receive pregnenolone or a placebo (a substance with no active drug).

Participant Groups

Group I: Pregnenolone Active Control 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

Same as active comparator, except placebo dispensed

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+