NCT05329779

Study on Allopregnanolone and Depression in Perimenopausal Women

Using Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women During the Perimenopause

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• 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 the progesterone metabolite allopregnanolone 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. The investigators 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 experimentally induced by exogenous ALLO. This will be achieved by using the exogenous ALLO treatment, brexanolone, which is FDA-approved to treat depression in postpartum patients, 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 perimenopausal women.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	brexanolone	Brexanolone is a derivative of allopregnanolone, which is FDA-approved to treat postpartum depression.
DRUG	placebo	The placebo is a 0.45% sodium chloride infusion.

Timeline

• Start date: 2022-11-04
• Primary completion: 2023-07-18
• Completion: 2023-07-18
• First posted: 2022-04-15
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study