A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

NCT04442503 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 217-PPD-3012020-001424-34
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 82

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.

Conditions

Depression, Postpartum

Keywords

SAGE-217; Postpartum depression

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15

  The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of 17 individual items related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of the 17 individual items, ranges from 0 to 52; where a higher score indicates more depression. Negative change from baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for the analysis.

  Baseline and Day 15

Secondary Outcomes (11)

• Change From Baseline in the 17-item HAM-D Total Score

  Baseline, Days 3, 28 and 45

• Change From Baseline in Clinical Global Impressions - Severity Scale (CGI-S) Score

  Baseline and Day 15

• Percentage of Participants With HAM-D Response

  Days 15 and 45

• Percentage of Participants With HAM-D Remission

  Days 15 and 45

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

  Day 15

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received SAGE-217 matched-placebo capsules, orally, once daily for 14 days.

Drug: Placebo

SAGE-217 50 mg

EXPERIMENTAL

Participants received SAGE-217, 50 mg, capsules, orally, once daily for 14 days.

Drug: SAGE-217

Interventions

SAGE-217 DRUG

SAGE-217 oral capsules.

SAGE-217 50 mg

Placebo DRUG

SAGE-217 matched-placebo oral capsules.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (82)

Sage Investigational Site

Scottsdale, Arizona, 85258, United States

Location

Sage Investigational Site

Bentonville, Arkansas, 72712, United States

Location

Sage Investigational Site

Anaheim, California, 92805, United States

Location

Sage Investigational Site

Bellflower, California, 90706, United States

Location

Sage Investigational Site

Beverly Hills, California, 90212, United States

Location

Sage Investigational Site

Costa Mesa, California, 92627, United States

Location

Sage Investigational Site

Imperial, California, 92251, United States

Location

Sage Investigational Site

Lemon Grove, California, 91945, United States

Location

Sage Investigational Site

Norwalk, California, 90650, United States

Location

Sage Investigational Site

Oceanside, California, 92056, United States

Location

Sage Investigational Site

Orange, California, 92866, United States

Location

Sage Investigational Site

Orange, California, 92868, United States

Location

Sage Investigational Site

Redlands, California, 92374, United States

Location

Sage Investigational Site

San Bernardino, California, 92408, United States

Location

Sage Investigational Site

Sherman Oaks, California, 91403, United States

Location

Sage Investigational Site

Torrance, California, 90502, United States

Location

Sage Investigational Site

Aurora, Colorado, 80045, United States

Location

Sage Investigational Site

Norwich, Connecticut, 06360, United States

Location

Sage Investigational Site

Boynton Beach, Florida, 33435, United States

Location

Sage Investigational Site

Hialeah, Florida, 33012, United States

Location

Sage Investigational Site

Jacksonville, Florida, 32256, United States

Location

Sage Investigational Site

Miami, Florida, 33133, United States

Location

Sage Investigational Site

Miami Springs, Florida, 33166, United States

Location

Sage Investigational Site

Miramar, Florida, 33029, United States

Location

Sage Investigational Site

Orlando, Florida, 32801, United States

Location

Sage Investigational Site

Orlando, Florida, 32807, United States

Location

Sage Investigational Site

Pensacola, Florida, 35202, United States

Location

Sage Investigational Site

Pinellas Park, Florida, 33872, United States

Location

Sage Investigational Site

Pompano Beach, Florida, 33060, United States

Location

Sage Investigational Site

Alpharetta, Georgia, 30022, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30331, United States

Location

Sage Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Savannah, Georgia, 31405, United States

Location

Sage Investigational Site

Idaho Falls, Idaho, 83404, United States

Location

Sage Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

Sage Investigational Site

Lincolnwood, Illinois, 60712, United States

Location

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Wichita, Kansas, 67226, United States

Location

Sage Investigational Site

New Orleans, Louisiana, 70115, United States

Location

Sage Investigational Site

Boston, Massachusetts, 02114, United States

Location

Sage Investigational Site

Detroit, Michigan, 48201, United States

Location

Sage Investigational Site

Flowood, Mississippi, 39232, United States

Location

Sage Investigational Site

Saint Charles, Missouri, 63304, United States

Location

Sage Investigational Site

St Louis, Missouri, 63125, United States

Location

Sage Investigational Site

St Louis, Missouri, 63128, United States

Location

Sage Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Sage Investigational Site

Marlton, New Jersey, 08053, United States

Location

Sage Investigational Site

Brooklyn, New York, 11229, United States

Location

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Glen Oaks, New York, 11004, United States

Location

Sage Investigational Site

New York, New York, 10036, United States

Location

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Chapel Hill, North Carolina, 27599, United States

Location

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Charlotte, North Carolina, 28211, United States

Location

Sage Investigational Site

Denver, North Carolina, 28037, United States

Location

Sage Investigational Site

Beachwood, Ohio, 44122, United States

Location

Sage Investigational Site

Mayfield Heights, Ohio, 44124, United States

Location

Sage Investigational SIte

North Canton, Ohio, 44720, United States

Location

Sage Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Sage Investigational Site

Allentown, Pennsylvania, 18104, United States

Location

Sage Investigational Site

Moosic, Pennsylvania, 18507, United States

Location

Sage Investigational Site

Providence, Rhode Island, 02904, United States

Location

Sage Investigational site

Charleston, South Carolina, 29425, United States

Location

Sage Investigational Site

Dallas, Texas, 75231, United States

Location

Sage Investigational Site

Fort Worth, Texas, 76104, United States

Location

Sage Investigational Site

Houston, Texas, 77058, United States

Location

Sage Investigational Site

League City, Texas, 77573, United States

Location

Sage Investigational Site

Richardson, Texas, 75080, United States

Location

Sage Investigational Site

San Antonio, Texas, 78229, United States

Location

Sage Investigational Site

North Chesterfield, Virginia, 23235, United States

Location

Sage Investigational Site

Bellevue, Washington, 98007, United States

Location

Sage Investigational Site

Barcelona, 8003, Spain

Location

Sage Investigational Site

Barcelona, 8035, Spain

Location

Sage Investigational Site

Barcelona, 8041, Spain

Location

Sage Investigational Site

Collado Villalba, 28040, Spain

Location

Sage Investigational Site

Madrid, 28031, Spain

Location

Sage Investigational Site

Oviedo, 33011, Spain

Location

Sage Investigational Site

Sabadell, 8208, Spain

Location

Sage Investigational Site

Valladolid, 47012, Spain

Location

Sage Investigational Site

Vigo, 36213, Spain

Location

Sage Investigational Site

Runwell, Essex, SS11 7XX, United Kingdom

Location

Sage Investigational Site

Preston, Lancashire, PR2 8DW, United Kingdom

Location

Sage Investigational Site

Morpeth, Northumberland, NE61 2NU, United Kingdom

Location

Sage Investigational Site

Headington, Oxford, OX3 7JX, United Kingdom

Location

Sage Investigational Site

Maidstone, ME16 9NW, United Kingdom

Location

Related Publications (1)

• Deligiannidis KM, Meltzer-Brody S, Maximos B, Peeper EQ, Freeman M, Lasser R, Bullock A, Kotecha M, Li S, Forrestal F, Rana N, Garcia M, Leclair B, Doherty J. Zuranolone for the Treatment of Postpartum Depression. Am J Psychiatry. 2023 Sep 1;180(9):668-675. doi: 10.1176/appi.ajp.20220785. Epub 2023 Jul 26.

  PMID: 37491938 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

zuranolone

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: 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: June 18, 2020
• First Posted: June 22, 2020
• Study Start: June 8, 2020
• Primary Completion: March 15, 2022
• Study Completion: April 12, 2022
• Last Updated: November 30, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (9); GB (5); US (68)