drugset / Trial / NCT04273191

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

NCT04273191 ↗

Phase 4 Withdrawn Sage Therapeutics
NaSingle-groupOpen-labelOther

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.

Timeline

Start
2020-02
Primary completion
2021-08
Completion
2021-08

Outcome

Outcome not reported

Stopped: “Sage Therapeutics has decided not to proceed with this study at this time”

Drugs

EvaluationDrugModalityDoseRoute
Background Brexanolone Unknown — —

Indications