Purpose

This study aims to identify how the progesterone metabolite allopregnanolone affects behavior and neurobiology that may underlie perimenopausal depression.

Condition

Eligibility

Eligible Ages
Between 40 Years and 60 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Healthy perimenopausal women ages 40 to 60 years - Depressive symptoms - Able to read Arabic numerals and perform simple arithmetic - Able to provide written informed consent

Exclusion Criteria

  • Use of medications to treat depression - Systemic hormone therapy - Contraindicated medications with brexanolone - Other psychiatric illnesses that are considered to be primary - Current suicidal ideation - Active substance use disorders - Unstable medical conditions - Obstructive sleep apnea or other primary sleep disorders - Abnormal hepatic and renal function - Known allergy to progesterone, exogenous allopregnanolone, or brexanolone - History of head injury resulting in loss of consciousness > 20 min - Inability to comply with barrier contraceptive methods - Known intellectual disability - Investigator judgement that study participation constitutes substantial risk given medical or psychiatric condition - Current or recent participation in clinical trial expected to interfere with risk of or interpretation of study data - Inability to comply with study procedures

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
brexanolone
Participants will receive a continuous 60-hr intravenous infusion of brexanolone
  • Drug: brexanolone
    Brexanolone is a derivative of allopregnanolone, which is FDA-approved to treat postpartum depression.
    Other names:
    • Zulresso
    • allopregnanolone
Placebo Comparator
placebo
Participants will receive a continuous 60-hr infusion of placebo
  • Drug: placebo
    The placebo is a 0.45% sodium chloride infusion.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Aleta Wiley, MPH MSc
617-525-9627
awiley1@bwh.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.