Study on Allopregnanolone and Depression in Women Across the Menopause Transition
NCT06238700 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-05-14
Summary
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
pregnenolone
Pregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement.
- OTHER
-
placebo
Placebo pills are identical-appearing capsules containing cellulose
Sponsors & Collaborators
-
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
Katherine Burdick, PhD · Columbia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-14
- Primary Completion
- 2027-07-31
- Completion
- 2027-08-31
Countries
- United States
Study Locations
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