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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ambulatory female ≥18 years of age.
Participant has a current diagnosis of postpartum depression (PPD), as confirmed by the investigator.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 3
Awards & highlights
Study Summary
This study is evaluating whether a medication can be safely administered in a home setting.
Eligible Conditions
- Postpartum Depression
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation
Secondary outcome measures
Number of Use-Related Issues Related to the Home Administration of ZULRESSO®
Percentage of Participants With Medication Error
Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO®
+1 moreSide effects data
From 2022 Phase 4 trial • 52 Patients • NCT0505960012%
Fatigue
10%
Headache
7%
Somnolence
7%
Infusion site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
ZULRESSO®
Trial Design
1Treatment groups
Experimental Treatment
Group I: ZULRESSO®Experimental Treatment1 Intervention
Participants received a 60-hour single continuous intravenous (IV) infusion of ZULRESSO®, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a dose taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZULRESSO®
2021
Completed Phase 4
~60
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Who is running the clinical trial?
Sage TherapeuticsLead Sponsor
49 Previous Clinical Trials
11,709 Total Patients Enrolled
8 Trials studying Postpartum Depression
564 Patients Enrolled for Postpartum Depression
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Wisconsin
How old are they?
18 - 65
What site did they apply to?
Virtual Site (recruiting nationwide)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
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