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A Study to Evaluate SAGE-547 in Patients With Severe Postpartum Depression

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. Identifier: NCT02942004
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : September 10, 2018
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 two dose levels of SAGE-547 Injection in up to 120 adult female subjects diagnosed with severe postpartum depression

Condition or disease Intervention/treatment Phase
Severe Postpartum Depression Drug: SAGE-547 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 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-547 Injection in the Treatment of Adult Female Subjects With Severe Postpartum Depression and Adult Female Subjects With Moderate Postpartum Depression
Study Start Date : July 2016
Actual Primary Completion Date : September 24, 2017
Actual Study Completion Date : October 19, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SAGE-547 Standard Dose
Drug: SAGE-547
Experimental: SAGE-547 Lower Dose
Drug: SAGE-547
Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Effect of SAGE-547 on depressive symptoms in subjects with severe postpartum depression compared to placebo injection as measured by the change from baseline in Hamilton Rating Scale for Depression (HAMD) total score [ Time Frame: 3 Days ]

Secondary Outcome Measures :
  1. Safety and tolerability of SAGE-547 compared with placebo as measured by the change from baseline in the incidence of AEs, vital signs, clinical laboratory evaluations, and ECG parameters [ Time Frame: 30 Days ]
  2. Safety of SAGE-547 compared to placebo as measured by the change from baseline in suicidal ideation and behavior assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) score [ Time Frame: 30 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

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 breastmilk to their 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 Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)
  • Subject is ≤ six months postpartum
  • Subject must be amenable to IV therapy

Key Exclusion Criteria:

  • Active psychosis
  • Attempted suicide associated with index case of postpartum depression
  • Medical history of bipolar disorders, 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 identifier (NCT number): NCT02942004

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Sponsors and Collaborators
Sage Therapeutics
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Study Director: Helen Colquhoun, MD Sage Therapeutics

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sage Therapeutics Identifier: NCT02942004     History of Changes
Other Study ID Numbers: 547-PPD-202 B
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Central Nervous System Depressants
Physiological Effects of Drugs