RecruitingNot ApplicableNCT06238700

Study on Allopregnanolone and Depression in Women Across the Menopause Transition

Targeting Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women Across the Menopause Transition

Sponsor

Brigham and Women's Hospital

Enrollment

80 participants

Start Date

May 14, 2024

Study Type

INTERVENTIONAL

Conditions

Depression

Summary

This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.

Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 60 Years

Inclusion Criteria5

Healthy women ages 40 to 60 years in the menopause transition
Depressive symptoms
Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study
Able to read Arabic numerals and perform simple arithmetic
Able to provide written informed consent

Exclusion Criteria16

Systemic hormone therapy
Contraindicated medications with pregnenolone
Systemic corticosteroid
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 pregnenolone
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