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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
Awards & highlights

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
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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:
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I have been diagnosed with PTSD and my score is 38 or higher.
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I haven't changed my mental health meds in the last 4 weeks.
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I am not pregnant or breastfeeding.
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I use benzodiazepines or opioids.

Timeline

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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,986 Total Patients Enrolled
Christine E. Marx, MD MAPrincipal InvestigatorDurham VA Medical Center, Durham, NC
3 Previous Clinical Trials
410 Total Patients Enrolled
Jennifer C Naylor, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
2 Previous Clinical Trials
198 Total Patients Enrolled
~56 spots leftby Jun 2028
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