Who is eligible for clinical trial NCT06238700?

Participants must meet protocol criteria for Depression. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06238700 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-24

Study on Allopregnanolone and Depression in Women Across the Menopause Transition (NCT06238700)

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Beth Israel Deaconess Medical Center

🩺 Plain-English Summary (8th-Grade Level)

This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (17 items).

Location: Beth Israel Deaconess Medical Center — Boston, Massachusetts

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Healthy women ages 40 to 60 years in the menopause transition
Depressive symptoms
Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study
Able to read Arabic numerals and perform simple arithmetic
Able to provide written informed consent

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Systemic hormone therapy
Contraindicated medications with pregnenolone
Systemic corticosteroid
Other psychiatric illnesses that are considered to be primary
Current suicidal ideation
Active substance use disorders
Unstable medical conditions
Obstructive sleep apnea or other primary sleep disorders
Abnormal hepatic and renal function
Known allergy to progesterone, exogenous allopregnanolone, or pregnenolone
History of head injury resulting in loss of consciousness \> 20 min

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Beth Israel Deaconess Medical Center — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗