Study on Allopregnanolone and Depression in Perimenopausal Women

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Brexanolone; Pregnanolone

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