An interventional study of pregnenolone and placebo in Depression, sponsored by Beth Israel Deaconess Medical Center. Recruiting at 1 site in United States. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Other
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.
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, placebo-controlled trial. By manipulating ALLO levels together with key measurement of depression domains, this study harnesses the endocrine biology of perimenopause to explicate behavioral and neurobiological mechanisms underlying depression in women across the menopause transition.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 80 is close to the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will take 250mg of pregnenolone twice per day (daily total=500mg) for four weeks
Dietary Supplement: pregnenolone
Participants will take placebo twice per day for four weeks
Other: placebo
Pregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement.
Placebo pills are identical-appearing capsules containing cellulose
Within-person change in score on the Ruminative Responses Scale
The Ruminative Responses Scale (RRS) comprises 22 items which ask how frequently the participant thinks certain statements when they feel depressed. Each item is scored from 1-4. Total scores range from 22-88 with higher scores indicating more severe rumination.
Time frame: Baseline to 2 weeks
Plan to share: No
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Beth Israel Deaconess Medical Center