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NCT02978326 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression

A Phase 3 study of Postpartum Depression, sponsored by Biogen.

Completed
Registry status
Phase 3
Development phase
276
Enrollment target
20
Study locations

NCT02978326 is a Phase 3 study of Postpartum Depression that has completed, run by Biogen. The registered enrollment target is 276 participants, below the 527-participant average among 38 other Postpartum Depression trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT02978326, a Phase 3 study of Postpartum Depression, has completed, sponsored by Biogen.

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

Study Summary

The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).

Conditions Studied

Postpartum Depression

Interventions

  • DRUG Placebo
  • DRUG SAGE-217 15/20 mg Oral Solution
  • DRUG SAGE 217 30 mg Capsules

Study Locations (20)

Florida

  • Sage Investigational Site - Aventura
  • Sage Investigational Site - Miami
  • Sage Investigational Site - Orlando
  • Sage Investigational Site - Pensacola
  • Sage Investigational SIte - Pinellas Park

California

  • Sage Investigational Site - Beverly Hills
  • Sage Investigational Site - Oceanside
  • Sage Investigational Site - Wildomar

Georgia

  • Sage Investigational Site - Atlanta
  • Sage Investigational Site - Decatur

Louisiana

  • Sage Investigational Site - Lake Charles
  • Sage Investigational Site - New Orleans

New York

  • Sage Investigational Site - Manhasset
  • Sage Investigational Site - New York

Arkansas

  • Sage Investigational Site - Little Rock

District of Columbia

  • Sage Investigational Site - Washington D.C.

Illinois

  • Sage Investigational Site - Hoffman Estates

Trial Details

FieldValue
Enrollment Target 276 participants
Start Date 2017-01-04
Est. Completion 2018-12-11
Phase Phase 3

Sponsor

Biogen

334 total trials

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What the Registry Record Tells You About NCT02978326

The ClinicalTrials.gov registry entry for NCT02978326 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 527-participant average among 38 other Postpartum Depression trials with a reported enrollment target (48% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Postpartum Depression appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT02978326 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT02978326 about?

NCT02978326 is a clinical study titled "A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression". The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day...

What is the current status of trial NCT02978326?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2017-01-04. Estimated completion is 2018-12-11.

What conditions does trial NCT02978326 study?

This clinical trial studies the following conditions: Postpartum Depression.

What interventions are being tested in trial NCT02978326?

The interventions under investigation include: Placebo (DRUG), SAGE-217 15/20 mg Oral Solution (DRUG), SAGE 217 30 mg Capsules (DRUG).

Who is sponsoring clinical trial NCT02978326?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02978326 being conducted?

This trial has 20 study locations across Arkansas, California, District of Columbia, 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.