Effects of pregnenolone on depression in menopausal women
Targeting Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women Across the Menopause Transition
This study is testing if a dietary supplement called pregnenolone can help reduce depression in menopausal women by boosting a hormone that may be low during this time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06238700 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 40 to 60 years experiencing depressive symptoms during the menopause transition.
Not a fit: Patients currently on systemic hormone therapy or with primary psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment approach for alleviating depression in perimenopausal women.
How similar studies have performed: While the approach of manipulating allopregnanolone levels is innovative, similar studies have shown promise in understanding hormonal influences on mood disorders.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Hadine Joffe, MD MSc — Brigham and Women's Hospital
- Study coordinator: Aleta Wiley, MPH
- Email: awiley1@bwh.harvard.edu
- Phone: 617-525-9627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.