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

NCT ID: NCT04442503

Last Updated: 2023-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

Study Completion Date

2022-04-12

Brief Summary

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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

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

Conditions

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Depression, Postpartum

Keywords

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SAGE-217 Postpartum depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SAGE-217 matched-placebo oral capsules.

SAGE-217 50 mg

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

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 oral capsules.

Interventions

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SAGE-217

SAGE-217 oral capsules.

Intervention Type DRUG

Placebo

SAGE-217 matched-placebo oral capsules.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sage Investigational Site

Scottsdale, Arizona, United States

Site Status

Sage Investigational Site

Bentonville, Arkansas, United States

Site Status

Sage Investigational Site

Anaheim, California, United States

Site Status

Sage Investigational Site

Bellflower, California, United States

Site Status

Sage Investigational Site

Beverly Hills, California, United States

Site Status

Sage Investigational Site

Costa Mesa, California, United States

Site Status

Sage Investigational Site

Imperial, California, United States

Site Status

Sage Investigational Site

Lemon Grove, California, United States

Site Status

Sage Investigational Site

Norwalk, California, United States

Site Status

Sage Investigational Site

Oceanside, California, United States

Site Status

Sage Investigational Site

Orange, California, United States

Site Status

Sage Investigational Site

Orange, California, United States

Site Status

Sage Investigational Site

Redlands, California, United States

Site Status

Sage Investigational Site

San Bernardino, California, United States

Site Status

Sage Investigational Site

Sherman Oaks, California, United States

Site Status

Sage Investigational Site

Torrance, California, United States

Site Status

Sage Investigational Site

Aurora, Colorado, United States

Site Status

Sage Investigational Site

Norwich, Connecticut, United States

Site Status

Sage Investigational Site

Boynton Beach, Florida, United States

Site Status

Sage Investigational Site

Hialeah, Florida, United States

Site Status

Sage Investigational Site

Jacksonville, Florida, United States

Site Status

Sage Investigational Site

Miami, Florida, United States

Site Status

Sage Investigational Site

Miami Springs, Florida, United States

Site Status

Sage Investigational Site

Miramar, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

Site Status

Sage Investigational Site

Pensacola, Florida, United States

Site Status

Sage Investigational Site

Pinellas Park, Florida, United States

Site Status

Sage Investigational Site

Pompano Beach, Florida, United States

Site Status

Sage Investigational Site

Alpharetta, Georgia, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Decatur, Georgia, United States

Site Status

Sage Investigational Site

Savannah, Georgia, United States

Site Status

Sage Investigational Site

Idaho Falls, Idaho, United States

Site Status

Sage Investigational Site

Hoffman Estates, Illinois, United States

Site Status

Sage Investigational Site

Lincolnwood, Illinois, United States

Site Status

Sage Investigational Site

Wichita, Kansas, United States

Site Status

Sage Investigational Site

New Orleans, Louisiana, United States

Site Status

Sage Investigational Site

Boston, Massachusetts, United States

Site Status

Sage Investigational Site

Detroit, Michigan, United States

Site Status

Sage Investigational Site

Flowood, Mississippi, United States

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Sage Investigational Site

Saint Charles, Missouri, United States

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Sage Investigational Site

St Louis, Missouri, United States

Site Status

Sage Investigational Site

St Louis, Missouri, United States

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Sage Investigational Site

Las Vegas, Nevada, United States

Site Status

Sage Investigational Site

Marlton, New Jersey, United States

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Sage Investigational Site

Brooklyn, New York, United States

Site Status

Sage Investigational Site

Glen Oaks, New York, United States

Site Status

Sage Investigational Site

New York, New York, United States

Site Status

Sage Investigational Site

Chapel Hill, North Carolina, United States

Site Status

Sage Investigational Site

Charlotte, North Carolina, United States

Site Status

Sage Investigational Site

Denver, North Carolina, United States

Site Status

Sage Investigational Site

Beachwood, Ohio, United States

Site Status

Sage Investigational Site

Mayfield Heights, Ohio, United States

Site Status

Sage Investigational SIte

North Canton, Ohio, United States

Site Status

Sage Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Sage Investigational Site

Allentown, Pennsylvania, United States

Site Status

Sage Investigational Site

Moosic, Pennsylvania, United States

Site Status

Sage Investigational Site

Providence, Rhode Island, United States

Site Status

Sage Investigational site

Charleston, South Carolina, United States

Site Status

Sage Investigational Site

Dallas, Texas, United States

Site Status

Sage Investigational Site

Fort Worth, Texas, United States

Site Status

Sage Investigational Site

Houston, Texas, United States

Site Status

Sage Investigational Site

League City, Texas, United States

Site Status

Sage Investigational Site

Richardson, Texas, United States

Site Status

Sage Investigational Site

San Antonio, Texas, United States

Site Status

Sage Investigational Site

North Chesterfield, Virginia, United States

Site Status

Sage Investigational Site

Bellevue, Washington, United States

Site Status

Sage Investigational Site

Barcelona, , Spain

Site Status

Sage Investigational Site

Barcelona, , Spain

Site Status

Sage Investigational Site

Barcelona, , Spain

Site Status

Sage Investigational Site

Collado Villalba, , Spain

Site Status

Sage Investigational Site

Madrid, , Spain

Site Status

Sage Investigational Site

Oviedo, , Spain

Site Status

Sage Investigational Site

Sabadell, , Spain

Site Status

Sage Investigational Site

Valladolid, , Spain

Site Status

Sage Investigational Site

Vigo, , Spain

Site Status

Sage Investigational Site

Runwell, Essex, United Kingdom

Site Status

Sage Investigational Site

Preston, Lancashire, United Kingdom

Site Status

Sage Investigational Site

Morpeth, Northumberland, United Kingdom

Site Status

Sage Investigational Site

Headington, Oxford, United Kingdom

Site Status

Sage Investigational Site

Maidstone, , United Kingdom

Site Status

Countries

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United States Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37491938 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2020-001424-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

217-PPD-301

Identifier Type: -

Identifier Source: org_study_id