Targeting Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women Across the Menopause Transition
Brigham and Women's Hospital
Summary
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.
Description
Midlife women are burdened with depression risk that is at least partly attributed to changing reproductive steroid dynamics across a prolonged reproductive transition. We 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 induced by pregnenolone. This will be achieved by using the over-the-counter dietary supplement, pregnenolone, in a randomized, double-blind, parallel-arm, pla…
Eligibility
- Age range
- 40–60 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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 * Obst…
Interventions
- Dietary Supplementpregnenolone
Pregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement.
- Otherplacebo
Placebo pills are identical-appearing capsules containing cellulose
Location
- Brigham and Women's HospitalBoston, Massachusetts