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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Sage Therapeutics
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics
ClinicalTrials.gov Identifier:
NCT02942004
First received: October 20, 2016
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Severe Postpartum Depression
Drug: SAGE-547
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sage Therapeutics:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • 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 ]

Estimated Enrollment: 120
Study Start Date: July 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAGE-547 Standard Dose
Intravenous
Drug: SAGE-547
Experimental: SAGE-547 Lower Dose
Intravenous
Drug: SAGE-547
Placebo Comparator: Placebo
Intravenous
Drug: Placebo

  Eligibility

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 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02942004

Contacts
Contact: Samantha Meltzer-Brody, MD samantha_meltzer-brody@med.unc.edu

  Show 29 Study Locations
Sponsors and Collaborators
Sage Therapeutics
Investigators
Study Director: Helen Colquhoun, MD Sage Therapeutics
  More Information

Additional Information:
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02942004     History of Changes
Other Study ID Numbers: 547-PPD-202 B
Study First Received: October 20, 2016
Last Updated: April 7, 2017

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

ClinicalTrials.gov processed this record on April 21, 2017