A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
Public ClinicalTrials.gov record NCT02978326. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02978326
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 276 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 4, 2017 (Actual)
- Primary completion
- Nov 15, 2018 (Actual)
- Completion
- Dec 11, 2018 (Actual)
- Last update posted
- Dec 15, 2023
2017 – 2018
United States locations
- U.S. sites
- 27
- U.S. states
- 15
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sage Investigational Site | Little Rock | Arkansas | 72209 | — |
| Sage Investigational Site | Beverly Hills | California | 90212 | — |
| Sage Investigational Site | Oceanside | California | 92056 | — |
| Sage Investigational Site | Wildomar | California | 92595 | — |
| Sage Investigational Site | Washington D.C. | District of Columbia | 20011 | — |
| Sage Investigational Site | Aventura | Florida | 33027 | — |
| Sage Investigational Site | Miami | Florida | 33173 | — |
| Sage Investigational Site | Orlando | Florida | 32807 | — |
| Sage Investigational Site | Pensacola | Florida | 32502 | — |
| Sage Investigational SIte | Pinellas Park | Florida | 33782 | — |
| Sage Investigational Site | Atlanta | Georgia | 30331 | — |
| Sage Investigational Site | Decatur | Georgia | 30030 | — |
| Sage Investigational Site | Hoffman Estates | Illinois | 60169 | — |
| Sage Investigational Site | Owensboro | Kentucky | 42303 | — |
| Sage Investigational Site | Lake Charles | Louisiana | 70629 | — |
| Sage Investigational Site | New Orleans | Louisiana | 70115 | — |
| Sage Investigational Site | Saint Charles | Missouri | 63304 | — |
| Sage Investigational Site | Las Vegas | Nevada | 89102 | — |
| Sage Investigational Site | Manhasset | New York | 11030 | — |
| Sage Investigational Site | New York | New York | 10036 | — |
| Sage Investigational Site | Chapel Hill | North Carolina | 27599 | — |
| Sage Investigational Site | Raleigh | North Carolina | 27612 | — |
| Sage Investigational Site | Providence | Rhode Island | 02904 | — |
| Sage Investigational Site | Fort Worth | Texas | 76060 | — |
| Sage Investigational Site | Houston | Texas | 77058 | — |
| Sage Investigational Site | Richardson | Texas | 75080 | — |
| Sage Investigational Site | Orem | Utah | 84058 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02978326, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 15, 2023 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02978326 live on ClinicalTrials.gov.