A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)

NCT02942004 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 547-PPD-202 B
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 32

Brief Summary

The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.

Conditions

Postpartum Depression

Keywords

Severe Postpartum Depression; SAGE-547

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score

  The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

  Baseline, Hour 60

Secondary Outcomes (11)

• Change From Baseline in HAM-D Total Score at Day 30

  Baseline, Day 30

• Change From Baseline in HAM-D Total Score

  Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14, and 21

• Percentage of Participants With HAM-D Response

  Hour 60, Days 7 and 30

• Percentage of Participants With HAM-D Remission

  Hour 60, Days 7 and 30

• Change From Baseline in HAM-D Bech 6 Subscale

  Baseline, Hour 60, Days 7 and 30

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants received infusion rates equivalent to either the 60 micrograms per kilogram per hour (μg/kg/h) or 90 μg/kg/h group.

Drug: Placebo

SAGE-547 60 μg/kg/h

EXPERIMENTAL

Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).

Drug: SAGE-547 60 μg/kg/h

SAGE-547 90 μg/kg/h

EXPERIMENTAL

Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).

Drug: SAGE-547 90 μg/kg/h

Interventions

Placebo DRUG

Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h.

Placebo

SAGE-547 60 μg/kg/h DRUG

Intravenous infusion of SAGE-547.

SAGE-547 60 μg/kg/h

SAGE-547 90 μg/kg/h DRUG

Intravenous infusion of SAGE-547.

SAGE-547 90 μg/kg/h

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female participants with postpartum depression defined as those who a major depressive episode that began no earlier than the third trimester and no later than the first four weeks following delivery, as diagnosed by Structured Clinical Interview Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th Edition Axis I Disorders (SCID-I), a Hamilton Rating Scale for Depression (HAM-D) total score of ≥26 at screening and Day 1 (prior to dosing), and who were ≤6 months postpartum at screening.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s) from just prior to receiving study drug through nine days (Day 12) after the end of the infusion
• Participants 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)
• Participant had a HAM-D total score of ≥26 at screening and Day 1 (prior to dosing)
• Participant was ≤6 months postpartum at screening
• Participant was amenable to IV therapy

You may not qualify if:

• Active psychosis
• Attempted suicide associated with index case of postpartum depression
• Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (32)

Sage Investigational Site

Chandler, Arizona, 85226, United States

Location

Sage Investigational Site

Rogers, Arkansas, 72758, United States

Location

Sage Investigational Site

Lemon Grove, California, 91945, United States

Location

Sage Investigational Site

Orange, California, 92868, United States

Location

Sage Investigational Site

Ventura, California, 93003, United States

Location

Sage Investigational Site

Gainesville, Florida, 32607, United States

Location

Sage Investigational Site

Miami, Florida, 33147, United States

Location

Sage Investigational Site

Miramar, Florida, 33027, United States

Location

Sage Investigational Site

Orlando, Florida, 32807, United States

Location

Sage Investigational Site

Pensacola, Florida, 32502, United States

Location

Sage Investigational Site

Pinellas Park, Florida, 33782, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30331, United States

Location

Sage Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

Sage Investigational Site

Wichita, Kansas, 67226, United States

Location

Sage Investigational Site

Edgewood, Kentucky, 41017, United States

Location

Sage Investigational Site

Owensboro, Kentucky, 42303, United States

Location

Sage Investigational Site

Boston, Massachusetts, 02114, United States

Location

Sage Investigational Site

Boston, Massachusetts, 02115, United States

Location

Sage Investigational Site

Flowood, Mississippi, 39232, United States

Location

Sage Investigational Site

Marlton, New Jersey, 08053, United States

Location

Sage Investigational Site

Glen Oaks, New York, 11004, United States

Location

Sage Investigational Site

Chapel Hill, North Carolina, 27514, United States

Location

Sage Investigational Site

Charlotte, North Carolina, 28211, United States

Location

Sage Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Sage Investigational Site

Columbus, Ohio, 43210, United States

Location

Sage Investigational Site

Dayton, Ohio, 45417, United States

Location

Sage Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Sage Investigational Site

Houston, Texas, 77030, United States

Location

Sage Investigational Site

Houston, Texas, 77058, United States

Location

Sage Investigational Site

Richardson, Texas, 75080, United States

Location

Sage Investigational Site

San Antonio, Texas, 78229, United States

Location

Sage Investigational Site

Orem, Utah, 84058, United States

Location

Related Publications (2)

• Gerbasi ME, Meltzer-Brody S, Acaster S, Fridman M, Bonthapally V, Hodgkins P, Kanes SJ, Eldar-Lissai A. Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making. J Womens Health (Larchmt). 2021 Mar;30(3):385-392. doi: 10.1089/jwh.2020.8483. Epub 2020 Nov 12.

  PMID: 33181049 DERIVED

• Meltzer-Brody S, Colquhoun H, Riesenberg R, Epperson CN, Deligiannidis KM, Rubinow DR, Li H, Sankoh AJ, Clemson C, Schacterle A, Jonas J, Kanes S. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet. 2018 Sep 22;392(10152):1058-1070. doi: 10.1016/S0140-6736(18)31551-4. Epub 2018 Aug 31. Erratum In: Lancet. 2018 Sep 29;392(10153):1116. doi: 10.1016/S0140-6736(18)32288-8.

  PMID: 30177236 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Depression, Postpartum

Interventions

brexanolone

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Monitor
• Organization: Sage Therapeutics

info@sagerx.com

617-299-8380

Study Officials

• Helen Colquhoun, MD

  Sage Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 21, 2016
• Study Start: August 1, 2016
• Primary Completion: September 24, 2017
• Study Completion: October 19, 2017
• Last Updated: October 14, 2025
• Results First Posted: June 13, 2019

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)