A Study to Evaluate SAGE-217 in Subjects With Severe Postpartum Depression
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02978326 |
Recruitment Status :
Completed
First Posted : November 30, 2016
Last Update Posted : November 20, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postpartum Depression | Drug: SAGE-217 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 153 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | December 2016 |
Actual Primary Completion Date : | November 15, 2018 |
Actual Study Completion Date : | December 11, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: SAGE-217 dosing
SAGE-217
|
Drug: SAGE-217 |
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo |
- Effect of SAGE-217 on depressive symptoms in subjects with severe postpartum depression compared to placebo as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score [ Time Frame: 14 days ]
- Safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, and electrocardiogram (ECG) parameters [ Time Frame: 75 days ]
- Safety and tolerability of SAGE-217 compared to placebo as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 75 days ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Subject either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s)
- Subject has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for DSM-5 Axis I Disorders (SCID-I)
- Subject is ≤ six months postpartum
Key Exclusion Criteria:
- Active psychosis
- Attempted suicide associated with current episode of postpartum depression
- Medical history of seizures
- Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
Note: suicidal ideation is not an exclusion. Other protocol-defined inclusion/exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978326
United States, Arizona | |
Sage Investigational Site | |
Chandler, Arizona, United States, 85226 | |
United States, Arkansas | |
Sage Investigational Site | |
Little Rock, Arkansas, United States, 72209 | |
United States, California | |
Sage Investigational Site | |
Corona, California, United States, 92879 | |
Sage Investigational Site | |
Oceanside, California, United States, 92056 | |
Sage Investigational Site | |
Riverside, California, United States, 92506 | |
Sage Investigational Site | |
San Bernardino, California, United States, 92408 | |
Sage Investigational Site | |
Wildomar, California, United States, 92595 | |
United States, District of Columbia | |
Sage Investigational Site | |
Washington, District of Columbia, United States, 20011 | |
United States, Florida | |
Sage Investigational Site | |
Aventura, Florida, United States, 33027 | |
Sage Investigational Site | |
Gainesville, Florida, United States, 32607 | |
Sage Investigational Site | |
Orlando, Florida, United States, 32807 | |
Sage Investigational Site | |
Pensacola, Florida, United States, 32502 | |
Sage Investigational SIte | |
Pinellas Park, Florida, United States, 33782 | |
United States, Georgia | |
Sage Investigational Site | |
Atlanta, Georgia, United States, 30331 | |
Sage Investigational Site | |
Decatur, Georgia, United States, 30030 | |
United States, Illinois | |
Sage Investigational Site | |
Hoffman Estates, Illinois, United States, 60169 | |
United States, Kentucky | |
Sage Investigational Site | |
Owensboro, Kentucky, United States, 42303 | |
United States, Louisiana | |
Sage Investigational Site | |
Lake Charles, Louisiana, United States, 70629 | |
Sage Investigational Site | |
New Orleans, Louisiana, United States, 70115 | |
United States, Missouri | |
Sage Investigational Site | |
Saint Charles, Missouri, United States, 63304 | |
United States, Nebraska | |
Sage Investigational Site | |
Omaha, Nebraska, United States, 68114 | |
United States, Nevada | |
Sage Investigational Site | |
Las Vegas, Nevada, United States, 89102 | |
United States, New Jersey | |
Sage Investigational Site | |
Princeton, New Jersey, United States, 08540 | |
United States, New York | |
Sage Investigational Site | |
Amherst, New York, United States, 14226 | |
Sage Investigational Site | |
Manhasset, New York, United States, 11030 | |
Sage Investigational Site | |
New York, New York, United States, 10022 | |
Sage Investigational Site | |
New York, New York, United States, 10036 | |
United States, North Carolina | |
Sage Investigational Site | |
Chapel Hill, North Carolina, United States, 27599 | |
Sage Investigational Site | |
Raleigh, North Carolina, United States, 27612 | |
United States, Oklahoma | |
Sage Investigational Site | |
Oklahoma City, Oklahoma, United States, 73116 | |
United States, Pennsylvania | |
Sage Investigational Site | |
Allentown, Pennsylvania, United States, 18104 | |
United States, Texas | |
Sage Investigational Site | |
Fort Worth, Texas, United States, 76060 | |
Sage Investigational Site | |
Houston, Texas, United States, 77058 | |
Sage Investigational Site | |
Richardson, Texas, United States, 75080 | |
Sage Investigational Site | |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
Sage Investigational Site | |
Orem, Utah, United States, 84058 | |
United States, Virginia | |
Sage Investigational Site | |
Charlottesville, Virginia, United States, 22903 | |
United States, Washington | |
Sage Investigational Site | |
Bellevue, Washington, United States, 98007 |
Study Director: | Christopher Silber, MD | Sage Therapeutics |
Responsible Party: | Sage Therapeutics |
ClinicalTrials.gov Identifier: | NCT02978326 |
Other Study ID Numbers: |
217-PPD-201 |
First Posted: | November 30, 2016 Key Record Dates |
Last Update Posted: | November 20, 2019 |
Last Verified: | November 2019 |
Postpartum Care |
Depression, Postpartum Depression Depressive Disorder Behavioral Symptoms |
Mood Disorders Mental Disorders Puerperal Disorders Pregnancy Complications |