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NCT05059600 · ClinicalTrials.gov registry record · Phase 4

A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting

A Phase 4 study of Postpartum Depression, sponsored by Supernus Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
52
Enrollment target
6
Study locations

NCT05059600: Completed Phase 4 study of Postpartum Depression, sponsored by Supernus Pharmaceuticals.

NCT05059600 is a Phase 4 study of Postpartum Depression that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 52 participants, below the 474-participant average among 47 other Postpartum Depression trials with a reported enrollment target (89% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05059600, a Phase 4 study of Postpartum Depression, has completed, sponsored by Supernus Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
52 participants
Enrollment target
6
Study locations

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.

Primary Outcome

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to the nearest single de

Conditions Studied

Postpartum Depression

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

FieldValue
Enrollment Target 52 participants
Start Date 2021-10-08
Est. Completion 2022-07-14
Phase Phase 4
Supernus Pharmaceuticals

57 total trials

What the finished NCT05059600 record still lists

NCT05059600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 474-participant average among 47 other Postpartum Depression trials with a reported enrollment target (89% lower).

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.

NCT05059600 lists 6 locations in 4 states (California, Florida, New York).

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.

What interventions are being tested in trial NCT05059600?

The interventions under investigation include: ZULRESSO® (DRUG).

Who is sponsoring clinical trial NCT05059600?

This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Postpartum Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05059600's enrollment target sits among peer trials

52 38th of 47 higher than 10 of 47 other Postpartum Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Postpartum Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05059600, the US trial registry maintained by the National Library of Medicine. NCT05059600 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.