Actively Recruiting
Study on Allopregnanolone and Depression in Women Across the Menopause Transition
Led by Beth Israel Deaconess Medical Center · Updated on 2026-05-14
80
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.
CONDITIONS
Official Title
Study on Allopregnanolone and Depression in Women Across the Menopause Transition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Systemic hormone therapy
- Contraindicated medications with pregnenolone
- Systemic corticosteroid use
- Other primary psychiatric illnesses
- Current suicidal thoughts
- Active substance use disorders
- Unstable medical conditions
- Obstructive sleep apnea or other primary sleep disorders
- Abnormal liver or kidney function
- Allergy to progesterone, exogenous allopregnanolone, or pregnenolone
- History of head injury causing loss of consciousness longer than 20 minutes
- Cannot comply with barrier contraceptive methods
- Known intellectual disability
- Investigator judgment that participation poses substantial risk due to medical or psychiatric condition
- Current or recent participation in other clinical trials that may interfere with this study
- Inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
A
Aleta Wiley, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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