MedTrace Logo

A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)

NCT04273191 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-08-18

No results posted yet for this study

Summary

In this Phase 4 study, women who have been prescribed commercial ZULRESSO™ (brexanolone) by a physician as standard of care for postpartum depression (PPD) and who are planning to receive the infusion per United States Prescribing Information (USPI) at a Risk Evaluation and Mitigation Strategy (REMS)-certified healthcare center are being asked to participate to collect data on multimodal neuroimaging parameters in order to evaluate the relationship between changes in depressive symptoms and changes in neuroimaging parameters.

Conditions

Interventions

DRUG

Brexanolone

Brexanolone will be initiated and administered per the USPI and the associated REMS.

Sponsors & Collaborators

  • Sage Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-29
Primary Completion
2021-08-31
Completion
2021-08-31
FDA Drug
Yes

More Related Trials

Entities

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 NCT04273191 on ClinicalTrials.gov