A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)

Major Depressive Disorder Clinical Trial

Official title:

A Phase 3, Open-Label, 1-Year Study of the Safety, Tolerability, and Need for Re-Treatment With SAGE-217 in Adult Subjects With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864614
• Other study ID #: 217-MDD-303
• Status: Completed
• Phase: Phase 3
• Start date: February 27, 2019
• Est. completion date: June 22, 2023

Study information

• Verified date: December 2023
• Source: Sage Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1543
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.

2. Participant is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests.

3. Participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of =28 and a HAM-D total score of =20 at Screening and Day 1 (prior to dosing).

Exclusion Criteria:

1. Participant has attempted suicide associated with the current episode of MDD.

2. Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

3. Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• SAGE-217
SAGE-217

Locations

Country	Name	City	State
United States	Sage Investigational Site	Albuquerque	New Mexico
United States	Sage Investigational Site	Alpharetta	Georgia
United States	Sage Investigational Site	Anaheim	California
United States	Sage Investigational Site	Ann Arbor	Michigan
United States	Sage Investigational Site	Atlanta	Georgia
United States	Sage Investigational Site	Austin	Texas
United States	Sage Investigational Site	Beachwood	Ohio
United States	Sage Investigational Site	Bellevue	Washington
United States	Sage Investigational Site	Brooklyn	New York
United States	Sage Investigational Site	Brooklyn	New York
United States	Sage Investigational Site	Cherry Hill	New Jersey
United States	Sage Investigational Site	Chicago	Illinois
United States	Sage Investigational Site	Chicago	Illinois
United States	Sage Investigational Site	Cincinnati	Ohio
United States	Sage Investigational site	Cincinnati	Ohio
United States	Sage Investigational Site	Cincinnati	Ohio
United States	Sage Investigational Site	Colorado Springs	Colorado
United States	Sage Investigational Site	Coral Springs	Florida
United States	Sage Investigational Site	Costa Mesa	California
United States	Sage Investigational Site	Cromwell	Connecticut
United States	Sage Investigational Site	Dallas	Texas
United States	Sage Investigational Site	Dothan	Alabama
United States	Sage Investigational Site	Glendale	California
United States	Sage Investigational Site	Houston	Texas
United States	Sage Investigational Site	Houston	Texas
United States	Sage Investigational Site	Irvine	California
United States	Sage Investigational Site	Jacksonville	Florida
United States	Sage Investigational Site	Lincoln	Nebraska
United States	Sage Investigational Site	Los Alamitos	California
United States	Sage Investigational Site	Marietta	Georgia
United States	Sage Investigational site	Marlton	New Jersey
United States	Sage Investigational Site	Miami	Florida
United States	Sage Investigational Site	Mount Kisco	New York
United States	Sage Investigational Site	Newport	Texas
United States	Sage Investigational Site	North Canton	Ohio
United States	Sage Investigational Site	Norwich	Connecticut
United States	Sage Investigational Site	Oceanside	California
United States	Sage Investigational Site	Oklahoma City	Oklahoma
United States	Sage Investigational Site	Orange	California
United States	Sage Investigational Site	Orlando	Florida
United States	Sage Investigational Site	Orlando	Florida
United States	Sage Investigational Site	Pensacola	Florida
United States	Sage Investigational Site	Phoenix	Arizona
United States	Sage Investigational Site	Plymouth Meeting	Pennsylvania
United States	Sage Investigational Site	Princeton	New Jersey
United States	Sage Investigational Site	Riverside	California
United States	Sage Investigational Site	Saint Charles	Missouri
United States	Sage Investigational Site	San Diego	California
United States	Sage Investigational Site	Savannah	Georgia
United States	Sage Investigational Site	Temecula	California
United States	Sage Investigational Site	Watertown	Massachusetts
United States	Sage Investigational Site	Wichita Falls	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Sage Therapeutics	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by the incidence and severity of adverse events.		52 Weeks
Primary	Safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by the incidence of clinically significant changes from baseline in clinical laboratory measures.		52 Weeks
Primary	Safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by the incidence of clinically significant changes from baseline in vital signs.		52 Weeks
Primary	Safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by the incidence of clinically significant changes from baseline in electrocardiograms (ECGs).		52 Weeks
Primary	The safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by suicidal ideation and behavior using the Columbia Suicide Severity Rating Scale (C-SSRS).	The C-SSRS consists of a baseline evaluation that assesses the lifetime experience of the participants with suicidal ideation and behavior, and a post-baseline evaluation that focuses on suicidality since the last study visit. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe).	52 Weeks
Secondary	The need for re-treatment with SAGE-217 as assessed by the time to first re-treatment.		Up to 52 weeks
Secondary	The need for re-treatment with SAGE-217 as assessed by the number of participants achieving the requirements for re-treatment.		Up to 52 weeks
Secondary	The need for re-treatment with SAGE-217 as assessed by the number of re-treatment cycles for each participant.		Up to 52 weeks
Secondary	The response of initial treatment and/or re-treatment as assessed by change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) score.	The 17-item HAM-D scale is used for measuring severity of depression. The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms 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 total score can range from 0 to 52, and higher scores indicate a greater degree of depression.	Up to 52 weeks
Secondary	The response of initial treatment and/or re-treatment as assessed by percent of participants achieving HAM-D response at the end of each 14-day treatment period, defined as a =50% reduction in HAM-D score from baseline.	The 17-item HAM-D scale is used for measuring severity of depression. The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms 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 total score can range from 0 to 52, and higher scores indicate a greater degree of depression.	Up to 52 weeks
Secondary	The response of initial treatment and/or re-treatment as assessed by percent of participants achieving HAM-D remission at the end of each 14-day treatment (initial and/or re-treatment) period, defined as HAM-D total score =7.	The 17-item HAM-D scale is used for measuring severity of depression. The HAM-D total score comprises a sum of the 17 individual item scores. 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 total score can range from 0 to 52, and higher scores indicate a greater degree of depression.	Up to 52 weeks
Secondary	The response of initial treatment and/or re-treatment as assessed by percent of participants achieving Clinical Global Impression - Improvement (CGI-I) score.	The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The Investigator will rate the participant's total improvement compared to baseline, whether or not it is due entirely to drug treatment. Response choices include: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.	Up to 52 weeks
Secondary	The response of initial treatment and/or re-treatment as assessed by change from baseline in Clinical Global Impression - Severity (CGI-S) score.	The CGI-S uses a 7-point Likert scale to rate the severity of the participant's mental illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. Considering total clinical experience, a participant is 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.	Up to 52 weeks