Study on Allopregnanolone and Depression in Women Across the Menopause Transition
NCT ID: NCT06238700
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-05-14
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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pregnenolone
Participants will take 250mg of pregnenolone twice per day (daily total=500mg) for four weeks
pregnenolone
Pregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement.
placebo
Participants will take placebo twice per day for four weeks
placebo
Placebo pills are identical-appearing capsules containing cellulose
Interventions
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pregnenolone
Pregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement.
placebo
Placebo pills are identical-appearing capsules containing cellulose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
60 Years
FEMALE
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Natalie Feldman
Psychiatrist
Principal Investigators
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Hadine Joffe, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Katherine Burdick, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Aleta Wiley
Role: primary
Other Identifiers
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2024P000113
Identifier Type: -
Identifier Source: org_study_id