Back to results

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

Primary Purpose

Depression, Postpartum

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

SAGE-217

Placebo

About this trial

This is an interventional treatment trial for Depression, Postpartum focused on measuring SAGE-217, Postpartum depression

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

SAGE-217 50 mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

The CGI-S is a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who had the same diagnosis. A participant was assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7= extremely ill participants. A lower score indicates a better outcome. A negative change from baseline indicates improvement. MMRM was used for the analysis.

Percentage of Participants With HAM-D Response

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. HAM-D response was defined as a ≥50% reduction in HAM-D total score from baseline.

Percentage of Participants With HAM-D Remission

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. HAM-D remission was defined as having a HAM-D total score of ≤7.

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

The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it is due entirely to drug treatment. Response choices include 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The CGI-I was only rated at posttreatment assessments. By definition, all CGI-I assessments are evaluated against baseline conditions. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved."

Change From Baseline in Hamilton Rating Scale for Anxiety (HAM-A) Total Score

The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each 14-items were defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A total score was calculated as the sum of the 14 individual item scores. The scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56 where <17 indicated mild severity, 18 to 24, mild to moderate severity, and 25 to 30, moderate to severe severity. A negative change from baseline in HAM-A total score indicated improvement.

Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item is rated on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from baseline in MADRS total score indicated improvement.

Change From Baseline in HAM-D Subscale

17-item HAM-D scale is used for severity of depression. HAM-D subscales: Core subscale(depressed mood, feelings of guilt, suicide, work and activities, and retardation/20x100; Anxiety subscale[anxiety(psychic and somatic), somatic symptoms (gastrointestinal and general), hypochondriasis, and insight loss of weight]/18x100; Bech-6 subscale(depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general)/22x100; Maier score(depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic)/24x100. Each item was scored in range of 0 to 2 or 0 to 4 (0=none to 2 or 4=severe), higher score=more depression. 4 Subscale scores were calculated as sum of individual rating scores related to each subscale, divided by total possible score within subscale, multiplied by 100. Scores were transformed to scale of 0 to 100, with higher scores=more severe depression. Negative CFB=improvement. MMRM was used for analysis.

Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score

The EPDS is a self-rated depressive symptom severity scale specific to the perinatal period which consists of 10 individual items. Each item is rated on a 4-point scale ranging from 0 to 3 points. The EPDS total score is calculated as the sum of the 10 individual item scores, ranging from 0 points to 30 points with a higher score indicating more depression. A negative change indicates improvement.

Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score

The PHQ-9 is a self-rated depressive symptom severity scale to monitor severity over time for newly diagnosed participants or participants in current treatment for depression. Scoring was based on participants responses to 9 specific questions as follows: 0 = not at all; 1 = several days; 2 = more than half the days; and 3 = nearly every day. The score were calculated as the sum of the 9 individual item scores. The PHQ-9 total score was categorized as follows: 1 to 4 = minimal depression, 5 to 9 = mild depression, 10 to 14 = moderate depression, 15 to 19 = moderately severe depression; and 20 to 27 = severe depression. The PHQ-9 total score ranges from 1 to 27 with a higher score indicating more depression. A negative change from baseline indicates reduced depression. MMRM was used for the analysis.

Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.

Full Information

NCT ID

NCT04442503

First Posted

June 18, 2020

Last Updated

June 21, 2023

Sponsor

Sage Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04442503

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

June 8, 2020 (Actual)

Primary Completion Date

March 15, 2022 (Actual)

Study Completion Date

April 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sage Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Postpartum

Keywords

SAGE-217, Postpartum depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

SAGE-217 50 mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SAGE-217

Intervention Description

SAGE-217 oral capsules.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

SAGE-217 matched-placebo oral capsules.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and Day 15

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Days 3, 28 and 45

Title

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

Description

Time Frame

Baseline and Day 15

Title

Percentage of Participants With HAM-D Response

Description

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. HAM-D response was defined as a ≥50% reduction in HAM-D total score from baseline.

Time Frame

Days 15 and 45

Title

Percentage of Participants With HAM-D Remission

Description

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. HAM-D remission was defined as having a HAM-D total score of ≤7.

Time Frame

Days 15 and 45

Title

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

Description

Time Frame

Day 15

Title

Change From Baseline in Hamilton Rating Scale for Anxiety (HAM-A) Total Score

Description

Time Frame

Baseline and Day 15

Title

Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score

Description

Time Frame

Baseline and Day 15

Title

Change From Baseline in HAM-D Subscale

Description

Time Frame

Baseline and Day 15

Title

Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score

Description

Time Frame

Baseline, Days 3, 8,15, 21, 28 and 45

Title

Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score

Description

Time Frame

Baseline, Days 3, 8,15, 21, 28 and 45

Title

Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

Description

Time Frame

Up to Day 45

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Sage Investigational Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Sage Investigational Site

City

Bentonville

State/Province

Arkansas

ZIP/Postal Code

72712

Country

United States

Facility Name

Sage Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Facility Name

Sage Investigational Site

City

Bellflower

State/Province

California

ZIP/Postal Code

90706

Country

United States

Facility Name

Sage Investigational Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90212

Country

United States

Facility Name

Sage Investigational Site

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92627

Country

United States

Facility Name

Sage Investigational Site

City

Imperial

State/Province

California

ZIP/Postal Code

92251

Country

United States

Facility Name

Sage Investigational Site

City

Lemon Grove

State/Province

California

ZIP/Postal Code

91945

Country

United States

Facility Name

Sage Investigational Site

City

Norwalk

State/Province

California

ZIP/Postal Code

90650

Country

United States

Facility Name

Sage Investigational Site

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Sage Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92866

Country

United States

Facility Name

Sage Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Sage Investigational Site

City

Redlands

State/Province

California

ZIP/Postal Code

92374

Country

United States

Facility Name

Sage Investigational Site

City

San Bernardino

State/Province

California

ZIP/Postal Code

92408

Country

United States

Facility Name

Sage Investigational Site

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91403

Country

United States

Facility Name

Sage Investigational Site

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

Sage Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Sage Investigational Site

City

Norwich

State/Province

Connecticut

ZIP/Postal Code

06360

Country

United States

Facility Name

Sage Investigational Site

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33435

Country

United States

Facility Name

Sage Investigational Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Sage Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Sage Investigational Site

City

Miami Springs

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Sage Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Sage Investigational Site

City

Miramar

State/Province

Florida

ZIP/Postal Code

33029

Country

United States

Facility Name

Sage Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32801

Country

United States

Facility Name

Sage Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32807

Country

United States

Facility Name

Sage Investigational Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

35202

Country

United States

Facility Name

Sage Investigational Site

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33872

Country

United States

Facility Name

Sage Investigational Site

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33060

Country

United States

Facility Name

Sage Investigational Site

City

Alpharetta

State/Province

Georgia

ZIP/Postal Code

30022

Country

United States

Facility Name

Sage Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Sage Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Sage Investigational Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31405

Country

United States

Facility Name

Sage Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Sage Investigational Site

City

Hoffman Estates

State/Province

Illinois

ZIP/Postal Code

60169

Country

United States

Facility Name

Sage Investigational Site

City

Lincolnwood

State/Province

Illinois

ZIP/Postal Code

60712

Country

United States

Facility Name

Sage Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67226

Country

United States

Facility Name

Sage Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Sage Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Sage Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Sage Investigational Site

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Sage Investigational Site

City

Saint Charles

State/Province

Missouri

ZIP/Postal Code

63304

Country

United States

Facility Name

Sage Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63125

Country

United States

Facility Name

Sage Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Sage Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89102

Country

United States

Facility Name

Sage Investigational Site

City

Marlton

State/Province

New Jersey

ZIP/Postal Code

08053

Country

United States

Facility Name

Sage Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11229

Country

United States

Facility Name

Sage Investigational Site

City

Glen Oaks

State/Province

New York

ZIP/Postal Code

11004

Country

United States

Facility Name

Sage Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10036

Country

United States

Facility Name

Sage Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Sage Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28211

Country

United States

Facility Name

Sage Investigational Site

City

Denver

State/Province

North Carolina

ZIP/Postal Code

28037

Country

United States

Facility Name

Sage Investigational Site

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Sage Investigational Site

City

Mayfield Heights

State/Province

Ohio

ZIP/Postal Code

44124

Country

United States

Facility Name

Sage Investigational SIte

City

North Canton

State/Province

Ohio

ZIP/Postal Code

44720

Country

United States

Facility Name

Sage Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Sage Investigational Site

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18104

Country

United States

Facility Name

Sage Investigational Site

City

Moosic

State/Province

Pennsylvania

ZIP/Postal Code

18507

Country

United States

Facility Name

Sage Investigational Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02904

Country

United States

Facility Name

Sage Investigational site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Sage Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Sage Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Sage Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Sage Investigational Site

City

League City

State/Province

Texas

ZIP/Postal Code

77573

Country

United States

Facility Name

Sage Investigational Site

City

Richardson

State/Province

Texas

ZIP/Postal Code

75080

Country

United States

Facility Name

Sage Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Sage Investigational Site

City

North Chesterfield

State/Province

Virginia

ZIP/Postal Code

23235

Country

United States

Facility Name

Sage Investigational Site

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98007

Country

United States

Facility Name

Sage Investigational Site

City

Barcelona

ZIP/Postal Code

8003

Country

Spain

Facility Name

Sage Investigational Site

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

Facility Name

Sage Investigational Site

City

Barcelona

ZIP/Postal Code

8041

Country

Spain

Facility Name

Sage Investigational Site

City

Collado-Villalba

ZIP/Postal Code

28040

Country

Spain

Facility Name

Sage Investigational Site

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Sage Investigational Site

City

Oviedo

ZIP/Postal Code

33011

Country

Spain

Facility Name

Sage Investigational Site

City

Sabadell

ZIP/Postal Code

8208

Country

Spain

Facility Name

Sage Investigational Site

City

Valladolid

ZIP/Postal Code

47012

Country

Spain

Facility Name

Sage Investigational Site

City

Vigo

ZIP/Postal Code

36213

Country

Spain

Facility Name

Sage Investigational Site

City

Runwell

State/Province

Essex

ZIP/Postal Code

SS11 7XX

Country

United Kingdom

Facility Name

Sage Investigational Site

City

Preston

State/Province

Lancashire

ZIP/Postal Code

PR2 8DW

Country

United Kingdom

Facility Name

Sage Investigational Site

City

Morpeth

State/Province

Northumberland

ZIP/Postal Code

NE61 2NU

Country

United Kingdom

Facility Name

Sage Investigational Site

City

Headington

State/Province

Oxford

ZIP/Postal Code

OX3 7JX

Country

United Kingdom

Facility Name

Sage Investigational Site

City

Maidstone

ZIP/Postal Code

ME16 9NW

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Depression, Postpartum

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial