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Recruiting NCT06238700

Study on Allopregnanolone and Depression in Women Across the Menopause Transition

No phase Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pregnenolone, placebo.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: 40 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Targeting Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women Across the Menopause Transition

Overview

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

Detailed description

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

Identifiers

NCT: NCT06238700 · 2026P000017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗