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Evaluate SAGE-547 in Female Patients With Severe Postpartum Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285504
First Posted: November 7, 2014
Last Update Posted: April 26, 2017
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.
Information provided by (Responsible Party):
Sage Therapeutics
  Purpose
This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, PK, and efficacy of SAGE-547 Injection in adult female patients diagnosed with severe postpartum depression (PPD).

Condition Intervention Phase
Postpartum Depression Drug: SAGE-547 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Proof-of-Concept Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-547 Injection in the Treatment of Adult Female Patients With Severe Postpartum Depression

Resource links provided by NLM:


Further study details as provided by Sage Therapeutics:

Primary Outcome Measures:
  • Safety and tolerability of SAGE-547 measured by mean changes from baseline in clinical laboratory measures, vital signs, and ECGs; physical examination; and concomitant medication usage [ Time Frame: 34 days ]

Secondary Outcome Measures:
  • Pharmacokinetic (PK) profile of SAGE-547 as measured by AUC, Cmax, Tmax, Css, Cavg. [ Time Frame: 3 days ]
  • Effects of SAGE-547 on patient symptom response evaluated by changes from baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) and individual Clinical Global Impression-Improvement (CGI-I) Scale scores [ Time Frame: 4 days ]

Enrollment: 4
Study Start Date: September 2014
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAGE-547 Drug: SAGE-547
Intravenous

  Eligibility

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

Inclusion Criteria:

  • Adult females, 18-45 years old who experienced a Major Depressive Episode in the postpartum period beginning within the first 4 weeks following delivery
  • Patient has ceased lactating, or if still lactating has already fully and permanently weaned their infant; if still actively breastfeeding, patient must agree to cease giving breast milk to their infant prior to study entry

Exclusion Criteria:

  • Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, or eyes, ears, or nose and throat (EENT) disorders
  • Active psychosis
  • Medical history of seizures
  Contacts and Locations
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): NCT02285504


Locations
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
Sponsors and Collaborators
Sage Therapeutics
Investigators
Study Chair: Stephen J Kanes, MD, PhD Sage Therapeutics
  More Information

Additional Information:
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02285504     History of Changes
Other Study ID Numbers: 547-PPD-201
First Submitted: October 22, 2014
First Posted: November 7, 2014
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Sage Therapeutics:
Postpartum depression

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