NCT06238700

Study on Allopregnanolone and Depression in Women Across the Menopause Transition

Targeting Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women Across the Menopause Transition

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Midlife women are burdened with depression risk that is at least partly attributed to changing reproductive steroid dynamics across a prolonged reproductive transition. We hypothesize that declining endogenous allopregnanolone (ALLO) levels across the menopause transition underlies perimenopausal depression. This mechanistic trial aims to amplify the contrast between lower endogenous ALLO levels in perimenopausal women and higher levels induced by pregnenolone. This will be achieved by using the over-the-counter dietary supplement, pregnenolone, in a randomized, double-blind, parallel-arm, placebo-controlled trial. By manipulating ALLO levels together with key measurement of depression domains, this study harnesses the endocrine biology of perimenopause to explicate behavioral and neurobiological mechanisms underlying depression in women across the menopause transition.

Conditions

• Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-14
• Primary completion: 2027-07-31
• Completion: 2027-08-31
• First posted: 2024-02-02
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States