Trials / Withdrawn
WithdrawnNCT04273191
A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
An Evaluation of Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sage Therapeutics · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Brexanolone | Brexanolone will be initiated and administered per the USPI and the associated REMS. |
Timeline
- Start date
- 2020-02-01
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
- First posted
- 2020-02-18
- Last updated
- 2020-08-18
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04273191. Inclusion in this directory is not an endorsement.