Study on Allopregnanolone and Depression in Women Across the Menopause Transition

What this trial studies

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

Conditions in scope

• Depression

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

Who can join

Women only · Ages 40 Years to 60 Years

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
• Obstructive sleep apnea or other primary sleep disorders

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-05-14
• Primary completion: 2027-07-31
• Last update posted: 2025-12-24
• First posted: 2024-02-02

Sponsor & contact

Lead sponsor: Brigham and Women's Hospital (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Within-person change in score on the Ruminative Responses Scale (Baseline 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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.