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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 : Recruiting
First Posted : November 30, 2016
Last Update Posted : August 20, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 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


Contacts
Contact: Handan Gunduz-Bruce, MD, MBA 617-949-2883 handan.gunduz-bruce@sagerx.com

  Show 37 Study Locations
Sponsors and Collaborators
Sage Therapeutics
Investigators
Study Director: Christopher Silber, MD Sage Therapeutics

Additional Information:
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: August 20, 2018
Last Verified: August 2018

Keywords provided by Sage Therapeutics:
Postpartum Care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications