A Study to Evaluate SAGE-547 in Patients With Moderate Postpartum Depression
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ClinicalTrials.gov Identifier: NCT02942017 |
Recruitment Status
:
Completed
First Posted
: October 21, 2016
Last Update Posted
: November 14, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Moderate Postpartum Depression | Drug: SAGE-547 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 108 participants |
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 |
Study Start Date : | July 2016 |
Actual Primary Completion Date : | September 17, 2017 |
Actual Study Completion Date : | October 11, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: SAGE-547
Intravenous
|
Drug: SAGE-547 |
Placebo Comparator: Placebo
Intravenous
|
Drug: Placebo |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

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): NCT02942017

Study Director: | Helen Colquhoun, MD | Sage Therapeutics |
Additional Information:
Responsible Party: | Sage Therapeutics |
ClinicalTrials.gov Identifier: | NCT02942017 History of Changes |
Other Study ID Numbers: |
547-PPD-202 C |
First Posted: | October 21, 2016 Key Record Dates |
Last Update Posted: | November 14, 2017 |
Last Verified: | November 2017 |
Additional relevant MeSH terms:
Depression Depressive Disorder Depression, Postpartum Behavioral Symptoms |
Mood Disorders Mental Disorders Puerperal Disorders Pregnancy Complications |