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A Study to Evaluate SAGE-547 in Patients With Moderate Postpartum Depression
This study is currently recruiting participants.
Verified August 2017 by Sage Therapeutics
Sponsor:
Sage Therapeutics
Information provided by (Responsible Party):
Sage Therapeutics
ClinicalTrials.gov Identifier:
NCT02942017
First received: October 20, 2016
Last updated: August 20, 2017
Last verified: August 2017
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Purpose
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in up to 100 adult female subjects diagnosed with moderate postpartum depression
| Condition | Intervention | Phase |
|---|---|---|
| Moderate Postpartum Depression | Drug: SAGE-547 Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
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 moderate 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: | 100 |
| 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
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 disorder
Note: suicidal ideation is not an exclusion. Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
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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: NCT02942017
Show 48 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02942017
Contacts
| Contact: Samantha Meltzer-Brody, MD | samantha_meltzer-brody@med.unc.edu |
Show 48 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: | NCT02942017 History of Changes |
| Other Study ID Numbers: |
547-PPD-202 C |
| Study First Received: | October 20, 2016 |
| Last Updated: | August 20, 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 August 22, 2017