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A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting
NCT05059600 · View on ClinicalTrials.gov ↗
Study Summary
The primary purpose of this study was to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting.
Conditions Studied
Interventions
- DRUG ZULRESSO®
Study Locations (6)
California
- Sage Investigational Site — Culver City
- Virtual Site (recruiting nationwide) — Culver City
Florida
- Sage Investigational Site — Miramar
- Sage Investigational Site — Pompano Beach
New York
- Sage Investigational Site — New York
Texas
- Sage Investigational Site — League City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-10-08 |
| Est. Completion | 2022-07-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05059600
The ClinicalTrials.gov registry entry for NCT05059600 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Supernus Pharmaceuticals, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Postpartum Depression appearing as the primary indexed condition, and to 1 intervention — of which ZULRESSO® is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05059600 reports 6 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05059600 about?
NCT05059600 is a clinical study titled "A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting". The primary purpose of this study was to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting.
What is the current status of trial NCT05059600?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2021-10-08. Estimated completion is 2022-07-14.
What conditions does trial NCT05059600 study?
This clinical trial studies the following conditions: Postpartum Depression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05059600?
The interventions under investigation include: ZULRESSO® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05059600?
This trial is sponsored by Supernus Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05059600 being conducted?
This trial has 6 study locations across California, Florida, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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