Study on Allopregnanolone and Depression in Women Across the Menopause Transition — SADIE-P  

Depression Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT06238700
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Contact: Aleta Wiley, MPH
• Phone: 617-525-9627
• Email: awiley1@bwh.harvard.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Completion date: August 31, 2027