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COMPLETED Phase 3

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

NCT02942017 · View on ClinicalTrials.gov ↗

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

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

43 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02942017

The ClinicalTrials.gov registry entry for NCT02942017 describes a study currently listed as completed. It is categorized as Phase 3, 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 108 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 2 interventions — of which Placebo 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: NCT02942017 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Kentucky. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02942017?

The interventions under investigation include: Placebo (DRUG), SAGE-547 90 μg/kg/h (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02942017?

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 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.

Related

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