Study on Allopregnanolone and Depression in Women Across the Menopause Transition

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT06238700
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • pregnenolone — DIETARY_SUPPLEMENT
    Pregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement.
  • placebo — OTHER
    Placebo pills are identical-appearing capsules containing cellulose

Study Details

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

Key Dates

Start date
May 14, 2024
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: pregnenolone
    Participants will take 250mg of pregnenolone twice per day (daily total=500mg) for four weeks
  • Placebo Comparator: placebo
    Participants will take placebo twice per day for four weeks

Primary Outcome Measure

Within-person change in score on the Ruminative Responses Scale [ Time Frame: Baseline to 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Aleta Wiley

Find similar trials in Boston, MA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Beth Israel Deaconess Medical Center· Boston, MA

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