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Study on Pregnenolone for Depression in Women During Menopause Transition

This study is looking at how a dietary supplement called pregnenolone might help with depression in women going through menopause. Researchers believe that changes in a natural body chemical called allopregnanolone (ALLO) during menopause may lead to depression. This study will give some women pregnenolone and others a placebo (an inactive pill) to see if increasing ALLO levels can improve depressive symptoms. You may be able to join if you are a healthy woman between 40 and 60 years old, are in the menopause transition, and have symptoms of depression. The study will measure changes in rumination (repeated negative thoughts) over two weeks to see if the treatment is successful. The current status of this study is unclear, but it plans to enroll 80 participants.

Study design
This is an interventional study that will compare pregnenolone to a placebo. It is a randomized, double-blind, parallel-arm, placebo-controlled trial, meaning participants will be randomly assigned to receive either pregnenolone or a placebo, and neither you nor the researchers will know which you are receiving. The study plans to enroll 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring changes in rumination is at 2 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06238700

Study on Allopregnanolone and Depression in Women Across the Menopause Transition

Recruiting
NAAges 40–60Interventional
Beth Israel Deaconess Medical Center
~80 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:pregnenoloneplacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Within-person change in score on the Ruminative Responses Scale
Measured over Baseline to 2 weeks

Conditions

Depression

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NCT06238700

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Katherine Burdick, PhD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Aleta Wiley, MPH
[email protected]
617-975-8706
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Within-person change in score on the Ruminative Responses ScaleBaseline to 2 weeks

    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.