Status:
RECRUITING
Study on Allopregnanolone and Depression in Perimenopausal Women
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Depression
Eligibility:
FEMALE
40-60 years
Phase:
PHASE4
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05329779
Start Date
November 4 2022
End Date
May 1 2026
Last Update
November 10 2022
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115