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Study on Allopregnanolone and Depression in Perimenopausal Women

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05329779
Collaborator
(none)
80
Enrollment
2
Arms
44
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study aims to identify how the progesterone metabolite allopregnanolone affects behavior and neurobiology that may underlie perimenopausal depression.

Condition or Disease Intervention/Treatment Phase
Phase 4

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. The investigators 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 experimentally induced by exogenous ALLO. This will be achieved by using the exogenous ALLO treatment, brexanolone, which is FDA-approved to treat depression in postpartum patients, 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 perimenopausal women.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Using Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women During the Perimenopause
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: brexanolone

Participants will receive a continuous 60-hr intravenous infusion of brexanolone

Drug: brexanolone
Brexanolone is a derivative of allopregnanolone, which is FDA-approved to treat postpartum depression.
Other Names:
  • Zulresso
  • allopregnanolone

    		•
    Placebo Comparator: placebo

    Participants will receive a continuous 60-hr infusion of placebo

    Drug: placebo
    The placebo is a 0.45% sodium chloride infusion.

    Outcome Measures

    Primary Outcome Measures

    1. Within-person change in score on the Ruminative Responses Scale [Baseline to 4 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Healthy perimenopausal women ages 40 to 60 years

    • Depressive symptoms

    • Able to read Arabic numerals and perform simple arithmetic

    • Able to provide written informed consent

    Exclusion Criteria:

    • Use of medications to treat depression

    • Systemic hormone therapy

    • Contraindicated medications with brexanolone

    • 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 brexanolone

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Brigham and Women's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hadine Joffe, MD MSc, Study Principal Investigator, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT05329779
    Other Study ID Numbers:
    • 2021P003137
    First Posted:
    Apr 15, 2022
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Pregnanolone
    Brexanolone

    Study Results

    No Results Posted as of Jul 19, 2022