A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression

NCT02614547 | Completed Phase 2 Results

• 1 other identifier: 547-PPD-202 A
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.

Conditions

Severe Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at End of Treatment Period (at 60 Hours) in 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. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

  Baseline, 60 Hours

Secondary Outcomes (8)

• Percentage of Participants With HAM-D Response

  60 Hours, Days 7 and 30

• Percentage of Participants With HAM-D Remission

  60 Hours, Days 7, and 30

• Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  Baseline, 60 Hours, Days 7 and 30

• Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response

  60 Hours, Days 7 and 30

• Change From Baseline in HAM-D Bech 6 Subscale

  Baseline, 60 Hours, Days 7 and 30

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received infusion rates of placebo matched to SAGE-547.

Drug: Placebo

SAGE-547

EXPERIMENTAL

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

Drug: SAGE-547

Interventions

SAGE-547 DRUG

Administered as intravenous infusion.

SAGE-547

Placebo DRUG

Administered as intravenous infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant either must have ceased lactating at Screening; or if still lactating at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug.
• Participant 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 was less than or equal to (\<=) six months postpartum.
• Participant must be amenable to intravenous therapy.

You may not qualify if:

• Active psychosis.
• Attempted suicide associated with index case of postpartum depression.
• Medical history of seizures.
• Medical history of bipolar disorder.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (4)

Sage Investigational Site

Atlanta, Georgia, 30342, United States

Location

Sage Investigational Site

Worcester, Massachusetts, 01655, United States

Location

Sage Investigational Site

Chapel Hill, North Carolina, 27514, United States

Location

Sage Investigational Site

Philadelphia, Pennsylvania, 19104, 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

• Kanes S, Colquhoun H, Gunduz-Bruce H, Raines S, Arnold R, Schacterle A, Doherty J, Epperson CN, Deligiannidis KM, Riesenberg R, Hoffmann E, Rubinow D, Jonas J, Paul S, Meltzer-Brody S. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial. Lancet. 2017 Jul 29;390(10093):480-489. doi: 10.1016/S0140-6736(17)31264-3. Epub 2017 Jun 12.

  PMID: 28619476 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

• Stephen J Kanes, MD, PhD

  Sage Therapeutics

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 25, 2015
• Study Start: December 15, 2015
• Primary Completion: June 22, 2016
• Study Completion: June 22, 2016
• Last Updated: September 15, 2025
• Results First Posted: September 13, 2021

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)