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Corticosteroid

Pregnenolone for Anxiety and Depression

Phase 2

Waitlist Available

Led By Jennifer C Naylor, PhD

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 10 weeks

Awards & highlights

Study 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.Check my eligibility

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).See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,519 Total Patients Enrolled

Jennifer C Naylor, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC

2 Previous Clinical Trials

198 Total Patients Enrolled

Christine E. Marx, MD MAPrincipal InvestigatorDurham VA Medical Center, Durham, NC

3 Previous Clinical Trials

410 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants still able to enroll in this ongoing trial?

"Based on the information available on clinicaltrials.gov, this specific study is not actively seeking participants. The trial was initially posted on October 1st, 2024 and last updated on December 18th, 2023. However, it's worth noting that there are currently a total of 1609 other trials actively recruiting patients at this time."

Answered by AI

Which individuals meet the eligibility criteria for participation in this medical research study?

"To be considered for participation in this clinical trial, individuals must exhibit symptoms of both anxiety and depression. Additionally, candidates between the ages of 18 and 65 are eligible to apply. The study aims to recruit a total of 84 participants."

Answered by AI

Could individuals younger than 85 years old participate in this experimental study?

"For this study, only individuals aged between 18 and 65 are eligible. It is worth noting that there are a total of 297 clinical trials specifically targeting participants under the age of 18, while there are 1141 studies focusing on patients over the age of 65."

Answered by AI

Has the Food and Drug Administration (FDA) officially sanctioned the use of Pregnenolone?

"Based on the current Phase 2 trial, our team at Power rates Pregnenolone's safety as a 2. While there is some preliminary data supporting its safety, no evidence has been found yet regarding its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A New Intervention to Improve Function in Veterans With Anxiety and Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06188923.

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