Study on Allopregnanolone and Depression in Women Across the Menopause Transition

NCT06238700 | Recruiting DMC

• 1 other identifier: 2024P000113
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to 2 weeks

Study Arms (2)

pregnenolone

EXPERIMENTAL

Participants will take 250mg of pregnenolone twice per day (daily total=500mg) for four weeks

Dietary Supplement: pregnenolone

placebo

PLACEBO COMPARATOR

Participants will take placebo twice per day for four weeks

Other: placebo

Interventions

pregnenolone DIETARY_SUPPLEMENT

Pregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement.

pregnenolone

placebo OTHER

Placebo pills are identical-appearing capsules containing cellulose

placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Hadine Joffe, MD MSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Katherine Burdick, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleta Wiley, MPH

CONTACT

617-525-9627; awiley1@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 2, 2024
• Study Start: May 14, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)