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Study on Allopregnanolone and Depression in Perimenopausal Women

NCT05329779 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-01-22

Study results available
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Summary

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

Conditions

Interventions

DRUG

brexanolone

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

DRUG

placebo

The placebo is a 0.45% sodium chloride infusion.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2023-07-18
Completion
2023-07-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05329779 on ClinicalTrials.gov