Clinical trial NCT02978326: A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Depression
Keywords: Postpartum Care
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-11-30
Enrollment: 276
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 primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).

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

Eligibility criteria: Key Inclusion Criteria:

* Participant either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s)
* 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 the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Axis I Disorders (SCID-I)
* Participant was \<=six months postpartum.

Key Exclusion Criteria:

* Active psychosis
* Attempted suicide associated with current episode of postpartum depression
* Medical history of seizures
* Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria might apply.

Primary outcomes:
measure: Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15
timeFrame: Parts A and B: Baseline, Day 15
Secondary outcomes:
measure: Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45
timeFrame: Part B: Baseline, Days 3, 8, 21 and 45
measure: Parts A and B: Percentage of Participants With HAM-D Response
timeFrame: Part B: Days 3, 8, 15, 21 and 45
measure: Parts A and B: Percentage of Participants With HAM-D Remission
timeFrame: Part B: Days 3, 8, 15, 21 and 45
measure: Parts A and B: Change From Baseline in HAM-D Subscales Scores
timeFrame: Part B: Baseline, Days 3, 8, 15, 21 and 45
measure: Parts A and B: Change From Baseline in HAM-D Individual Item Scores
timeFrame: Part B: Baseline, Days 3, 8, 15, 21 and 45
measure: Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: Part B: Baseline, Days 3, 8, 15, 21 and 45
measure: Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
timeFrame: Part B: Days 3, 8, 15, 21 and 45
measure: Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
timeFrame: Part B: Baseline, Days 3, 8, 15, 21 and 45
measure: Parts A and B: Percentage of Participants With MADRS Response
timeFrame: Part B: Days 3, 8, 15, 21 and 45
measure: Parts A and B: Percentage of Participants With MADRS Remission
timeFrame: Part B: Days 3, 8, 15, 21 and 45
measure: Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Part A: Up to Day 75; Part B: Up to Day 45
measure: Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
timeFrame: Part B: From first dose of study drug up to 45 days
measure: Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations
timeFrame: Part B: From first dose of study drug up to 45 days
measure: Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate
timeFrame: Part B: Baseline, Days 8, 15, and 21
measure: Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval
timeFrame: Part B: Baseline, Days 8, 15, and 21
measure: Part B: Number of Participants With a Response of "Yes" to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Part B: Up to Day 45
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Sage Investigational Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Sage Investigational Site
state: California
city: Oceanside
country: United States
facility: Sage Investigational Site
state: California
city: Wildomar
country: United States
facility: Sage Investigational Site
state: California
city: Washington
country: United States
facility: Sage Investigational Site
state: District of Columbia
city: Aventura
country: United States
facility: Sage Investigational Site
state: Florida
city: Miami
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: Decatur
country: United States
facility: Sage Investigational Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Sage Investigational Site
state: Illinois
city: Owensboro
country: United States
facility: Sage Investigational Site
state: Kentucky
city: Lake Charles
country: United States
facility: Sage Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Sage Investigational Site
state: Louisiana
city: Saint Charles
country: United States
facility: Sage Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Sage Investigational Site
state: Nevada
city: Manhasset
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: Raleigh
country: United States
facility: Sage Investigational Site
state: North Carolina
city: Providence
country: United States
facility: Sage Investigational Site
state: Rhode Island
city: Fort Worth
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: Orem
country: United States
facility: Sage Investigational Site
state: Utah
Study officials:
References:
citation: Deligiannidis K, Lasser R, Gunduz-Bruce H, Silber C, Sankoh AJ, Li Si, et al. A Phase 3, Double-Blind, Placebo- Controlled Trial of SAGE-217 in Postpartum Depression: Assessment of Depressive Symptoms Across Multiple Measures. Abstract presented at: American Society of Clinical Psychopharmacology 2019 Annual Meeting; May 28-31, 2019; Scottsdale, AZ.
citation: Lasser R, Deligiannidis K, Gunduz-Bruce H, Silber C, Sankoh AJ, Li Si, et al. A Phase 3, Double-Blind, Placebo- Controlled Trial of SAGE-217 in Postpartum Depression: Topline Assessment of Secondary Efficacy Measures of Anxiety and Depression. Abstract presented at: American Society of Clinical Psychopharmacology 2019 Annual Meeting; May 28-31, 2019; Scottsdale, AZ.
citation: Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, Doherty J, Jonas J, Li S, Sankoh AJ, Silber C, Campbell AD, Werneburg B, Kanes SJ, Lasser R. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):951-959. doi: 10.1001/jamapsychiatry.2021.1559.