NCT02978326

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 4, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2018

Completed
3 years until next milestone

Results Posted

Study results publicly available

December 16, 2021

Completed
Last Updated

December 15, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

November 28, 2016

Results QC Date

November 15, 2021

Last Update Submit

November 27, 2023

Conditions

Postpartum Depression

Keywords

Postpartum Care

Outcome Measures

Primary Outcomes (1)

  • Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15

    The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. 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 HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.

    Parts A and B: Baseline, Day 15

Secondary Outcomes (16)

  • Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45

    Part B: Baseline, Days 3, 8, 21 and 45

  • Parts A and B: Percentage of Participants With HAM-D Response

    Part B: Days 3, 8, 15, 21 and 45

  • Parts A and B: Percentage of Participants With HAM-D Remission

    Part B: Days 3, 8, 15, 21 and 45

  • Parts A and B: Change From Baseline in HAM-D Subscales Scores

    Part B: Baseline, Days 3, 8, 15, 21 and 45

  • Parts A and B: Change From Baseline in HAM-D Individual Item Scores

    Part B: Baseline, Days 3, 8, 15, 21 and 45

  • +11 more secondary outcomes

Study Arms (3)

Part A: SAGE-217 15/20 mg Oral Solution

EXPERIMENTAL

Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.

Drug: SAGE-217 15/20 mg Oral Solution

Part B: Placebo

PLACEBO COMPARATOR

Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.

Drug: Placebo

Part B: SAGE 217 30 mg Capsules

EXPERIMENTAL

Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.

Drug: SAGE 217 30 mg Capsules

Interventions

SAGE-217 15/20 mg Oral SolutionDRUG

SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).

Part A: SAGE-217 15/20 mg Oral Solution
PlaceboDRUG

SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.

Part B: Placebo
SAGE 217 30 mg CapsulesDRUG

SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.

Part B: SAGE 217 30 mg Capsules

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Sage Investigational Site

Little Rock, Arkansas, 72209, United States

Location

Sage Investigational Site

Beverly Hills, California, 90212, United States

Location

Sage Investigational Site

Oceanside, California, 92056, United States

Location

Sage Investigational Site

Wildomar, California, 92595, United States

Location

Sage Investigational Site

Washington D.C., District of Columbia, 20011, United States

Location

Sage Investigational Site

Aventura, Florida, 33027, United States

Location

Sage Investigational Site

Miami, Florida, 33173, 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

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

Sage Investigational Site

Owensboro, Kentucky, 42303, United States

Location

Sage Investigational Site

Lake Charles, Louisiana, 70629, United States

Location

Sage Investigational Site

New Orleans, Louisiana, 70115, United States

Location

Sage Investigational Site

Saint Charles, Missouri, 63304, United States

Location

Sage Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Sage Investigational Site

Manhasset, New York, 11030, United States

Location

Sage Investigational Site

New York, New York, 10036, United States

Location

Sage Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

Sage Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Sage Investigational Site

Providence, Rhode Island, 02904, United States

Location

Sage Investigational Site

Fort Worth, Texas, 76060, United States

Location

Sage Investigational Site

Houston, Texas, 77058, United States

Location

Sage Investigational Site

Richardson, Texas, 75080, United States

Location

Sage Investigational Site

Orem, Utah, 84058, United States

Location

Related Publications (4)

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    PMID: 34190962RESULT

  • Deligiannidis KM, Citrome L, Huang MY, Acaster S, Fridman M, Bonthapally V, Lasser R, Kanes SJ. Effect of Zuranolone on Concurrent Anxiety and Insomnia Symptoms in Women With Postpartum Depression. J Clin Psychiatry. 2023 Jan 30;84(1):22m14475. doi: 10.4088/JCP.22m14475.

    PMID: 36724109DERIVED

Related Links

MeSH Terms

Conditions

Depression, Postpartum

Interventions

zuranoloneSolutions

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

Title
US Biogen Clinical Trial Center
Organization
Biogen
clinicaltrials@biogen.com
866-633-4636

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

November 28, 2016

First Posted

November 30, 2016

Study Start

January 4, 2017

Primary Completion

November 15, 2018

Study Completion

December 11, 2018

Last Updated

December 15, 2023

Results First Posted

December 16, 2021

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

More information

Locations

US(27)