Clinical trial NCT04442503: A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
Official title: A Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 in the Treatment of Adults With Severe Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression, Postpartum
Keywords: SAGE-217
Postpartum depression
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2020-06-22
Enrollment: 200
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 is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.

Detailed description: This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Inclusion Criteria:

* Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
* Participant 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 Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
* Participant is ≤12 months postpartum at screening and Day 1.

Exclusion Criteria:

* Participant is at significant risk of suicide or has attempted suicide associated with the current episode of PPD.
* Participant has active psychosis per investigator assessment.
* Participant has a medical history of nonfebrile seizures.
* Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
* Participant has a history of sleep apnea.

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

Primary outcomes:
measure: Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15
timeFrame: Baseline and Day 15
Secondary outcomes:
measure: Change From Baseline in the 17-item HAM-D Total Score
timeFrame: Baseline, Days 3, 28 and 45
measure: Change From Baseline in Clinical Global Impressions - Severity Scale (CGI-S) Score
timeFrame: Baseline and Day 15
measure: Percentage of Participants With HAM-D Response
timeFrame: Days 15 and 45
measure: Percentage of Participants With HAM-D Remission
timeFrame: Days 15 and 45
measure: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
timeFrame: Day 15
measure: Change From Baseline in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
timeFrame: Baseline and Day 15
measure: Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and Day 15
measure: Change From Baseline in HAM-D Subscale
timeFrame: Baseline and Day 15
measure: Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score
timeFrame: Baseline, Days 3, 8,15, 21, 28 and 45
measure: Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score
timeFrame: Baseline, Days 3, 8,15, 21, 28 and 45
measure: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to Day 45
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Sage Investigational Site
state: Arizona
city: Bentonville
country: United States
facility: Sage Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Sage Investigational Site
state: California
city: Bellflower
country: United States
facility: Sage Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Sage Investigational Site
state: California
city: Costa Mesa
country: United States
facility: Sage Investigational Site
state: California
city: Imperial
country: United States
facility: Sage Investigational Site
state: California
city: Lemon Grove
country: United States
facility: Sage Investigational Site
state: California
city: Norwalk
country: United States
facility: Sage Investigational Site
state: California
city: Oceanside
country: United States
facility: Sage Investigational Site
state: California
city: Orange
country: United States
facility: Sage Investigational Site
state: California
city: Orange
country: United States
facility: Sage Investigational Site
state: California
city: Redlands
country: United States
facility: Sage Investigational Site
state: California
city: San Bernardino
country: United States
facility: Sage Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: Sage Investigational Site
state: California
city: Torrance
country: United States
facility: Sage Investigational Site
state: California
city: Aurora
country: United States
facility: Sage Investigational Site
state: Colorado
city: Norwich
country: United States
facility: Sage Investigational Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Sage Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Sage Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Sage Investigational Site
state: Florida
city: Miami Springs
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: 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: Pompano Beach
country: United States
facility: Sage Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Sage Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Sage Investigational Site
state: Georgia
city: Idaho Falls
country: United States
facility: Sage Investigational Site
state: Idaho
city: Hoffman Estates
country: United States
facility: Sage Investigational Site
state: Illinois
city: Lincolnwood
country: United States
facility: Sage Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Sage Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: Sage Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Sage Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Sage Investigational Site
state: Michigan
city: Flowood
country: United States
facility: Sage Investigational Site
state: Mississippi
city: Saint Charles
country: United States
facility: Sage Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Sage Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Sage Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Sage Investigational Site
state: Nevada
city: Marlton
country: United States
facility: Sage Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Sage Investigational Site
state: New York
city: Glen Oaks
country: United States
facility: Sage Investigational Site
state: New York
city: New York
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: Denver
country: United States
facility: Sage Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Sage Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Sage Investigational Site
state: Ohio
city: North Canton
country: United States
facility: Sage Investigational SIte
state: Ohio
city: Oklahoma City
country: United States
facility: Sage Investigational Site
state: Oklahoma
city: Allentown
country: United States
facility: Sage Investigational Site
state: Pennsylvania
city: Moosic
country: United States
facility: Sage Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Sage Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Sage Investigational site
state: South Carolina
city: Dallas
country: United States
facility: Sage Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Sage Investigational Site
state: Texas
city: Houston
country: United States
facility: Sage Investigational Site
state: Texas
city: League City
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: North Chesterfield
country: United States
facility: Sage Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: Sage Investigational Site
state: Washington
city: Barcelona
country: Spain
facility: Sage Investigational Site
city: Barcelona
country: Spain
facility: Sage Investigational Site
city: Barcelona
country: Spain
facility: Sage Investigational Site
city: Collado-Villalba
country: Spain
facility: Sage Investigational Site
city: Madrid
country: Spain
facility: Sage Investigational Site
city: Oviedo
country: Spain
facility: Sage Investigational Site
city: Sabadell
country: Spain
facility: Sage Investigational Site
city: Valladolid
country: Spain
facility: Sage Investigational Site
city: Vigo
country: Spain
facility: Sage Investigational Site
city: Runwell
country: United Kingdom
facility: Sage Investigational Site
state: Essex
city: Preston
country: United Kingdom
facility: Sage Investigational Site
state: Lancashire
city: Morpeth
country: United Kingdom
facility: Sage Investigational Site
state: Northumberland
city: Headington
country: United Kingdom
facility: Sage Investigational Site
state: Oxford
city: Maidstone
country: United Kingdom
facility: Sage Investigational Site
Study officials:
References: