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

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ClinicalTrials.gov Identifier: NCT02978326
Recruitment Status : Completed
First Posted : November 30, 2016
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety and pharmacokinetics of SAGE-217 in approximately 140 adult female subjects diagnosed with severe postpartum depression.

Condition or disease Intervention/treatment Phase
Postpartum Depression Drug: SAGE-217 Drug: Placebo Phase 3

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAGE-217 dosing
SAGE-217
Drug: SAGE-217
Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Safety and tolerability of SAGE-217 compared to placebo as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 75 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


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Locations
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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
Sponsors and Collaborators
Sage Therapeutics
Investigators
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Study Director: Christopher Silber, MD Sage Therapeutics

Additional Information:
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02978326     History of Changes
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
Keywords provided by Sage Therapeutics:
Postpartum Care
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications