Clinical trial NCT02942004: A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Depression
Keywords: Severe Postpartum Depression
SAGE-547
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

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

Note: Other protocol-defined inclusion/exclusion criteria applied.

Primary outcomes:
measure: Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score
timeFrame: Baseline, Hour 60
Secondary outcomes:
measure: Change From Baseline in HAM-D Total Score at Day 30
timeFrame: Baseline, Day 30
measure: Change From Baseline in HAM-D Total Score
timeFrame: Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14, and 21
measure: Percentage of Participants With HAM-D Response
timeFrame: Hour 60, Days 7 and 30
measure: Percentage of Participants With HAM-D Remission
timeFrame: Hour 60, Days 7 and 30
measure: Change From Baseline in HAM-D Bech 6 Subscale
timeFrame: Baseline, Hour 60, Days 7 and 30
measure: Change From Baseline in HAM-D Individual Item Scores
timeFrame: Baseline, Hour 2, Hour 4, Hour 8, Hour 12, Hour 24, Hour 36, Hour 48, Hour 60, Hour 72 and Days 7, 14, 21 and 30
measure: Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline, Hour 60, Days 7 and 30
measure: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
timeFrame: Hour 60, Days 7 and 30
measure: Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score
timeFrame: Baseline, Hour 60, Days 7, 14, 21 and 30
measure: Percentage of Participants With Treatment-Emergent Adverse Events
timeFrame: Up to approximately 37 days.
measure: Time to Change in Antidepressant Medication
timeFrame: Up to approximately 37 days.
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Sage Investigational Site
state: Arizona
city: Rogers
country: United States
facility: Sage Investigational Site
state: Arkansas
city: Lemon Grove
country: United States
facility: Sage Investigational Site
state: California
city: Orange
country: United States
facility: Sage Investigational Site
state: California
city: Ventura
country: United States
facility: Sage Investigational Site
state: California
city: Gainesville
country: United States
facility: Sage Investigational Site
state: Florida
city: Miami
country: United States
facility: Sage Investigational Site
state: Florida
city: Miramar
country: United States
facility: Sage Investigational Site
state: Florida
city: Orlando
country: United States
facility: Sage Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Sage Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Sage Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Sage Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Sage Investigational Site
state: Kansas
city: Edgewood
country: United States
facility: Sage Investigational Site
state: Kentucky
city: Owensboro
country: United States
facility: Sage Investigational Site
state: Kentucky
city: Boston
country: United States
facility: Sage Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Sage Investigational Site
state: Massachusetts
city: Flowood
country: United States
facility: Sage Investigational Site
state: Mississippi
city: Marlton
country: United States
facility: Sage Investigational Site
state: New Jersey
city: Glen Oaks
country: United States
facility: Sage Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Sage Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Sage Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Sage Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Sage Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Sage Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Sage Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Sage Investigational Site
state: Texas
city: Houston
country: United States
facility: Sage Investigational Site
state: Texas
city: Richardson
country: United States
facility: Sage Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Sage Investigational Site
state: Texas
city: Orem
country: United States
facility: Sage Investigational Site
state: Utah
Study officials:
affiliation: Sage Therapeutics
name: Helen Colquhoun, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.