Study on Allopregnanolone and Depression in Perimenopausal Women

NCT05329779 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 2021P003137
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to identify how the progesterone metabolite allopregnanolone 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 4 days

Study Arms (2)

brexanolone

EXPERIMENTAL

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

Drug: brexanolone

placebo

PLACEBO COMPARATOR

Participants will receive a continuous 60-hr infusion of placebo

Drug: placebo

Interventions

brexanolone DRUG

Brexanolone is a derivative of allopregnanolone, which is FDA-approved to treat postpartum depression.

Also known as: Zulresso, allopregnanolone

brexanolone

placebo DRUG

The placebo is a 0.45% sodium chloride infusion.

placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Depression

Interventions

brexanolone; Pregnanolone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The study was terminated early due to operational feasibility. The decision to terminate the study was not related to any new or emerging safety concerns.

Results Point of Contact

• Title: Director of Research Program Management
• Organization: Brigham and Women's Hospital

awiley1@bwh.harvard.edu

617-525-9627

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: November 4, 2022
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)