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

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ClinicalTrials.gov Identifier: NCT02614547
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : August 8, 2017
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-547 Injection in adult female subjects diagnosed with severe postpartum depression

Condition or disease Intervention/treatment Phase
Severe Postpartum Depression Drug: SAGE-547 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SAGE-547
Intravenous
Drug: SAGE-547
Placebo Comparator: Placebo
Intravenous
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
Criteria

Key Inclusion Criteria:

  • Subject either must have ceased lactating at Screening; or if still lactating at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug.
  • 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 seizures
  • Medical history of bipolar 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): NCT02614547


Locations
United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72205
United States, Florida
Gainesville, Florida, United States, 32606
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
NeuroTrials Research, Inc.
Atlanta, Georgia, United States, 30342
United States, Kansas
Cypress Medical Research
Wichita, Kansas, United States, 67226
United States, Maryland
Johns Hopkins University Women's Mood Disorders
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, New Jersey
PRA Health Sciences
Marlton, New Jersey, United States, 08053
United States, North Carolina
University or North Carolina, Chapel Hill - Perinatal Psychiatry In-Patient Unit
Chapel Hill, North Carolina, United States, 27514
Charlotte, North Carolina, United States
United States, Ohio
The Ohio State University, Department of Psychiatry and Behavioral Health
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Sage Therapeutics
Investigators
Study Chair: Stephen J Kanes, MD, PhD Sage Therapeutics

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02614547     History of Changes
Other Study ID Numbers: 547-PPD-202 A
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

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