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

NCT03864614 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 217-MDD-303
• Study Type: interventional
• Target: 1,515
• Locations: 1 country
• Sites: 52

Brief 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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a participant 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, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. For Part A, a TEAE was defined as an AE with onset after the first dose of SAGE-217.

  Up to 52 Weeks

• Part B: Number of Participants With TEAEs

  An AE was any untoward medical occurrence in a participant 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, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. For Part B, a TEAE was defined as an AE with onset on or after the first dose of SAGE-217 in MDD-303B for the participants who received placebo + ADT in parent study, or an AE with onset on or after the ICF signoff in MDD-303B for the participants who received SAGE-217 + ADT in parent study.

  Up to 46 Weeks

• Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

  C-SSRS scale consisted of a baseline evaluation that assessed lifetime experience as well as past 24-month experience of participants for SI and SB and a postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation, if present. The C-SSRS SI items included: 1. wish to be dead, 2. non-specific active suicidal thoughts, 3. active SI with any methods, 4. active SI with some intent, and 5. active SI with a specific plan (5 being the most severe). C-SSRS SB items included 1. preparatory acts or behavior, 2. aborted attempt, 3. interrupted attempt, 4. actual attempt (non-fatal), and 5. completed suicide (5 being worst). Participants with at least one SI question answered Yes or at least one SB question answered Yes post-baseline for the specific period is counted under SI or SB respectively.

  Baseline up to 52 Weeks (Study Period 1-5)

• Part B: Number of Participants With Suicidal Ideation (SI) and Suicidal Behavior (SB) as Assessed by the C-SSRS

  C-SSRS scale consisted of a baseline evaluation that assessed lifetime experience as well as past 24-month experience of participants for SI and SB and a postbaseline (PB) evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation, if present. The C-SSRS SI items included: 1. wish to be dead, 2. non-specific active suicidal thoughts, 3. active SI with any methods, 4. active SI with some intent, and 5. active SI with a specific plan (5 being the most severe). C-SSRS SB items included 1. preparatory acts or behavior, 2. aborted attempt, 3. interrupted attempt, 4. actual attempt (non-fatal), and 5. completed suicide (5 being worst). Participants with at least one SI question answered Yes or at least one SB question answered Yes post-baseline for the specific period is counted under SI or SB respectively.

  Baseline up to 46 Weeks (Study Period 1-5)

Secondary Outcomes (18)

• Parts A and B: Time to First Repeat Treatment With SAGE-217

  Up to 52 Weeks

• Parts A and B: Number of Participants Who Achieved the Requirements for Repeat Treatment for SAGE-217

  Up to 52 Weeks

• Parts A and B: Number of Repeat Treatment Cycles of SAGE-217 for Each Participant

  Up to 52 Weeks

• Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 in Study Period 1

  Baseline, Day 15 in Study Period 1

• Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 of Each Treatment Cycle

  Baseline, Day 15 of treatment cycles 2, 3, 4, and 5

Study Arms (1)

SAGE-217

EXPERIMENTAL

Drug: SAGE-217

Interventions

SAGE-217 DRUG

SAGE-217

SAGE-217

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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).

You may not qualify if:

• Participant has attempted suicide associated with the current episode of MDD.
• Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
• Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.

Sponsors & Collaborators

• Biogen: lead

Study Sites (52)

Sage Investigational Site

Dothan, Alabama, 36303, United States

Location

Sage Investigational Site

Phoenix, Arizona, 85012, United States

Location

Sage Investigational Site

Anaheim, California, 92805, United States

Location

Sage Investigational Site

Costa Mesa, California, 92626, United States

Location

Sage Investigational Site

Glendale, California, 91206, United States

Location

Sage Investigational Site

Irvine, California, 92614, United States

Location

Sage Investigational Site

Los Alamitos, California, 90720, United States

Location

Sage Investigational Site

Oceanside, California, 92056, United States

Location

Sage Investigational Site

Orange, California, 92868, United States

Location

Sage Investigational Site

Riverside, California, 92503, United States

Location

Sage Investigational Site

San Diego, California, 92103, United States

Location

Sage Investigational Site

Temecula, California, 92591, United States

Location

Sage Investigational Site

Colorado Springs, Colorado, 80910, United States

Location

Sage Investigational Site

Cromwell, Connecticut, 06416, United States

Location

Sage Investigational Site

Norwich, Connecticut, 06360, United States

Location

Sage Investigational Site

Coral Springs, Florida, 33067, United States

Location

Sage Investigational Site

Jacksonville, Florida, 32256, United States

Location

Sage Investigational Site

Miami, Florida, 33122, 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, 32502, United States

Location

Sage Investigational Site

Alpharetta, Georgia, 30022, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30331, United States

Location

Sage Investigational Site

Marietta, Georgia, 30060, United States

Location

Sage Investigational Site

Savannah, Georgia, 31405, United States

Location

Sage Investigational Site

Chicago, Illinois, 60634, United States

Location

Sage Investigational Site

Chicago, Illinois, 60640, United States

Location

Sage Investigational Site

Watertown, Massachusetts, 02472, United States

Location

Sage Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Sage Investigational Site

Saint Charles, Missouri, 63304, United States

Location

Sage Investigational Site

Lincoln, Nebraska, 68526, United States

Location

Sage Investigational Site

Cherry Hill, New Jersey, 08002, United States

Location

Sage Investigational site

Marlton, New Jersey, 08053, United States

Location

Sage Investigational Site

Princeton, New Jersey, 08540, United States

Location

Sage Investigational Site

Albuquerque, New Mexico, 87109, United States

Location

Sage Investigational Site

Brooklyn, New York, 11229, United States

Location

Sage Investigational Site

Brooklyn, New York, 11235, United States

Location

Sage Investigational Site

Mount Kisco, New York, 10549, United States

Location

Sage Investigational Site

Beachwood, Ohio, 44122, United States

Location

Sage Investigational Site

Cincinnati, Ohio, 45212, United States

Location

Sage Investigational site

Cincinnati, Ohio, 45215, United States

Location

Sage Investigational Site

Cincinnati, Ohio, 45219, 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

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Sage Investigational Site

Austin, Texas, 78759, United States

Location

Sage Investigational Site

Dallas, Texas, 75231, United States

Location

Sage Investigational Site

Houston, Texas, 77030, United States

Location

Sage Investigational Site

Houston, Texas, 77081, United States

Location

Sage Investigational Site

Newport, Texas, 78712, United States

Location

Sage Investigational Site

Wichita Falls, Texas, 76309, United States

Location

Sage Investigational Site

Bellevue, Washington, 98007, United States

Location

Related Publications (1)

• Cutler AJ, Mattingly GW, Kornstein SG, Aaronson ST, Lasser R, Zhang H, Rana N, Brown C, Levin S, Miller C, Kotecha M, Forrestal F, Doherty J. Long-Term Safety and Efficacy of Initial and Repeat Treatment Courses With Zuranolone in Adult Patients With Major Depressive Disorder: Interim Results From the Open-Label, Phase 3 SHORELINE Study. J Clin Psychiatry. 2023 Dec 27;85(1):23m14845. doi: 10.4088/JCP.23m14845.

  PMID: 38153320 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

zuranolone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Monitor
• Organization: Sage Therapeutics

info@sagerx.com

(617) 299-8380

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: March 6, 2019
• Study Start: February 27, 2019
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: August 27, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (52)