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

Sponsor
Sage Therapeutics
Study ID
NCT04273191
Phase
PHASE4
Status
Withdrawn

Conditions

  • Postpartum Depression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 29, 2020
Status verified
Aug 2020
Primary completion
Aug 31, 2021
Completion
Aug 31, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Brexanolone
    Participants will receive a single dose of commercial brexanolone as part of standard of care.

Primary Outcome Measure

Change from Baseline to Post-Infusion on the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score [ Time Frame: Up to approximately 5 days ]

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