← Back to Search

Corticosteroid

Pregnenolone for Anxiety and Depression

Phase 2

Waitlist Available

Led By Christine E. Marx, MD MA

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women will be required to use a medically and study-approved non-hormonal contraceptive or otherwise not be of child-bearing potential

Be older than 18 years old

Must not have

PTSD diagnosis, as per the PCL-5, scores of 38 or higher

No changes in psychotropic medications for mental or physical health conditions 4 weeks prior to study randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 10 weeks

Summary

This trial aims to test the effectiveness of a medication called pregnenolone in treating symptoms of anxiety, depression, poor sleep quality, and chronic pain in Veterans. These symptoms often occur together and may

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Pregnenolone has been found to have minimal side effects and is generally well-tolerated by veterans. Specific side effect details are not provided but are expected to be mild based on previous research.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with PTSD and my score is 38 or higher.

Select...

I haven't changed my mental health meds in the last 4 weeks.

Select...

I am not pregnant or breastfeeding.

Select...

I use benzodiazepines or opioids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Brief Pain Inventory, Second Edition (BPI-II)

Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

Pittsburgh Sleep Quality Index (PSQI)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: PregnenoloneActive Control1 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: PlaceboPlacebo Group1 Intervention

Same as active comparator, except placebo dispensed

0 / 5Eligibility criteria met