Study on Allopregnanolone and Depression in Perimenopausal Women
Primary Purpose
Depression
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
brexanolone
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
brexanolone
placebo
Arm Description
Participants will receive a continuous 60-hr intravenous infusion of brexanolone
Participants will receive a continuous 60-hr infusion of placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05329779
First Posted
April 8, 2022
Last Updated
November 8, 2022
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05329779
Brief Title
Study on Allopregnanolone and Depression in Perimenopausal Women
Official Title
Using Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women During the Perimenopause
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to identify how the progesterone metabolite allopregnanolone 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
brexanolone
Arm Type
Experimental
Arm Description
Participants will receive a continuous 60-hr intravenous infusion of brexanolone
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a continuous 60-hr infusion of placebo
Intervention Type
Drug
Intervention Name(s)
brexanolone
Other Intervention Name(s)
Zulresso, allopregnanolone
Intervention Description
Brexanolone is a derivative of allopregnanolone, which is FDA-approved to treat postpartum depression.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
The placebo is a 0.45% sodium chloride infusion.
Primary Outcome Measure Information:
Title
Within-person change in score on the Ruminative Responses Scale
Description
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.
Time Frame
Baseline to 4 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleta Wiley, MPH MSc
Phone
617-525-9627
Email
awiley1@bwh.harvard.edu
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleta Wiley
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study on Allopregnanolone and Depression in Perimenopausal Women
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