Effects of allopregnanolone on depression in perimenopausal women
Using Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women During the Perimenopause
This study is testing if a treatment that raises allopregnanolone levels can help reduce depression in perimenopausal women.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05329779 on ClinicalTrials.gov |
What this trial studies
This study investigates how the progesterone metabolite allopregnanolone influences behavior and neurobiology related to depression in perimenopausal women. It focuses on the hypothesis that declining levels of allopregnanolone during the menopause transition contribute to increased depression risk. The trial employs a randomized, double-blind, parallel-arm, placebo-controlled design, using the FDA-approved treatment brexanolone to elevate allopregnanolone levels. By comparing these levels with those of a placebo, the study aims to elucidate the mechanisms underlying depression in this population.
Who should consider this trial
Good fit: Ideal candidates are healthy perimenopausal women aged 40 to 60 who exhibit depressive symptoms.
Not a fit: Patients currently on medications for depression or with other primary psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for perimenopausal women suffering from depression.
How similar studies have performed: Previous studies have shown promising results with brexanolone in treating depression, particularly in postpartum patients, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Aleta Wiley, MPH MSc
- Email: awiley1@bwh.harvard.edu
- Phone: 617-525-9627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.