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Evaluate SAGE-547 in Female 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: NCT02285504
Recruitment Status : Completed
First Posted : November 7, 2014
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Postpartum Depression Drug: SAGE-547 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
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
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SAGE-547 Drug: SAGE-547

Primary Outcome Measures :
  1. 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 :
  1. Pharmacokinetic (PK) profile of SAGE-547 as measured by AUC, Cmax, Tmax, Css, Cavg. [ Time Frame: 3 days ]
  2. 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 ]

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

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

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): NCT02285504

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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
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Study Chair: Stephen J Kanes, MD, PhD Sage Therapeutics

Additional Information:
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Responsible Party: Sage Therapeutics Identifier: NCT02285504     History of Changes
Other Study ID Numbers: 547-PPD-201
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Keywords provided by Sage Therapeutics:
Postpartum depression
Additional relevant MeSH terms:
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Depression, Postpartum
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Central Nervous System Depressants
Physiological Effects of Drugs