Effects of pregnenolone on depression in menopausal women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how increasing allopregnanolone levels through the dietary supplement pregnenolone may influence behavior and neurobiology related to depression in midlife women undergoing menopause. It focuses on the hypothesis that declining natural allopregnanolone levels contribute to perimenopausal depression. The trial is designed as a randomized, double-blind, placebo-controlled study, comparing the effects of pregnenolone against a placebo on depressive symptoms. Key measurements will assess the relationship between hormonal changes and depression during the menopause transition.

Why it matters

Who can join: the full rules

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

Where it's running

• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Katherine Burdick, PhD — Columbia University
• Study coordinator: Aleta Wiley, MPH
• Email: awiley3@bidmc.harvard.edu
• Phone: 617-975-8706

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.