Study on Allopregnanolone and Depression in Perimenopausal Women
Purpose
This study aims to identify how the progesterone metabolite allopregnanolone affects behavior and neurobiology that may underlie perimenopausal depression.
Condition
- Depression
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental brexanolone |
Participants will receive a continuous 60-hr intravenous infusion of brexanolone |
|
|
Placebo Comparator placebo |
Participants will receive a continuous 60-hr infusion of placebo |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
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.
