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NCT02942017 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)

A Phase 3 study of Postpartum Depression, sponsored by Supernus Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
108
Enrollment target
20
Study locations

NCT02942017 is a Phase 3 study of Postpartum Depression that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 108 participants, below the 532-participant average among 38 other Postpartum Depression trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT02942017, a Phase 3 study of Postpartum Depression, has completed, sponsored by Supernus Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
108 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.

Conditions Studied

Postpartum Depression

Interventions

  • DRUG Placebo
  • DRUG SAGE-547 90 μg/kg/h

Study Locations (20)

Florida

  • Sage Investigational Site - Gainesville
  • Sage Investigational Site - Miami
  • Sage Investigational Site - Miramar
  • Sage Investigational Site - Orlando
  • Sage Investigational Site - Pensacola
  • Sage Investigational Site - Pinellas Park

California

  • Sage Investigational Site - Lemon Grove
  • Sage Investigational Site - Orange
  • Sage Investigational Site - Ventura

Kentucky

  • Sage Investigational Site - Edgewood
  • Sage Investigational Site - Owensboro

Arizona

  • Sage Investigational Site - Chandler

Arkansas

  • Sage Investigational Site - Rogers

Georgia

  • Sage Investigational Site - Atlanta

Illinois

  • Sage Investigational Site - Hoffman Estates

Kansas

  • Sage Investigational Site - Wichita

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2016-07
Est. Completion 2017-10-11
Phase Phase 3

Sponsor

Supernus Pharmaceuticals

57 total trials

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What the Registry Record Tells You About NCT02942017

The ClinicalTrials.gov registry entry for NCT02942017 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 532-participant average among 38 other Postpartum Depression trials with a reported enrollment target (80% 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 2 interventions - of which Placebo is the first listed.

NCT02942017 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, California, Kentucky.

Frequently Asked Questions

What is clinical trial NCT02942017 about?

NCT02942017 is a clinical study titled "A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)". The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale...

What is the current status of trial NCT02942017?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2016-07. Estimated completion is 2017-10-11.

What conditions does trial NCT02942017 study?

This clinical trial studies the following conditions: Postpartum Depression.

What interventions are being tested in trial NCT02942017?

The interventions under investigation include: Placebo (DRUG), SAGE-547 90 μg/kg/h (DRUG).

Who is sponsoring clinical trial NCT02942017?

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

Where is trial NCT02942017 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. 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.