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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 is a Phase 4 study of Postpartum Depression that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 52 participants, below the 533-participant average among 38 other Postpartum Depression trials with a reported enrollment target (90% lower). The trial reports 6 study locations across 4 states.

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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.

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

Sponsor

Supernus Pharmaceuticals

57 total trials

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What the Registry Record Tells You About NCT05059600

The ClinicalTrials.gov registry entry for NCT05059600 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 533-participant average among 38 other Postpartum Depression trials with a reported enrollment target (90% lower). The listed sponsor is Supernus Pharmaceuticals, which has 57 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.