A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Subjects With Major Depressive Disorder

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF SAGE-217 WITH FIXED, REPEATED TREATMENT REGIMEN ON RELAPSE PREVENTION IN ADULTS WITH MAJOR DEPRESSIVE DISORDER

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002640-25-GB

Enrollment

546

Registered

2019-10-08

Start date

2019-12-09

Completion date

Unknown

Last updated

2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MAJOR DEPRESSIVE DISORDER MedDRA version: 21.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 100000004873

Interventions

Product Name: Sage-217 Pharmaceutical Form: Capsule INN or Proposed INN: Zuranolone CAS Number: 1632051-40-1 Current Sponsor code: SAGE-217 Other descriptive name: SGE-797

S-812217 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product N

S-812217 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Subject has a diagnosis of MDD as diagnosed by SCID-5-CT, with symptoms that have been present for at least a 4-week period. 2.Subject has had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode). 3.Subject is willing to delay start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study completion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 541 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1.Subject has attempted suicide associated with the current episode of MDD 2.Subject has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) will be used for this purpose. 3.Subject has a positive pregnancy test at screening or on Day 1 prior to dosing.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of SAGE-217 with a fixed, repeated treatment regimen in the prevention of relapse in subjects with major depressive disorder (MDD) who have responded to OL treatment with SAGE-217;Secondary Objective: To evaluate the long-term safety and tolerability of a fixed, repeated treatment regimen of SAGE-217 up to 1 year;Primary end point(s): The primary endpoint of this study is time to relapse during the double-blind (DB) Phase (days; from first dose of study drug in the DB Phase to relapse [date] during the DB Phase).;Timepoint(s) of evaluation of this end point: Symptom driven, up to 275 Days	—

Measure

Time frame

Main Objective: To evaluate the efficacy of SAGE-217 with a fixed, repeated treatment regimen in the prevention of relapse in subjects with major depressive disorder (MDD) who have responded to OL treatment with SAGE-217;Secondary Objective: To evaluate the long-term safety and tolerability of a fixed, repeated treatment regimen of SAGE-217 up to 1 year;Primary end point(s): The primary endpoint of this study is time to relapse during the double-blind (DB) Phase (days; from first dose of study drug in the DB Phase to relapse [date] during the DB Phase).;Timepoint(s) of evaluation of this end point: Symptom driven, up to 275 Days

—

Secondary

Measure	Time frame
Secondary end point(s): Percentage of subjects who relapse during the DB Phase • Change from baseline in the 17-item HAM-D total score at the end of each 14-day treatment period in the DB Phase. • HAM-D response at the end of each 14-day treatment period in the DB Phase, defined as a =50% reduction in HAM-D score from baseline • HAM-D remission at the end of each 14-day treatment period in the DB Phase, defined as HAM-D total score =7 • CGI-I response, defined as “much improved” or “very much improved”, at the end of each 14-day treatment period in the DB Phase • Change from baseline in Clinical Global Impression - Severity (CGI-S) score at the end of each 14-day treatment period in the DB Phase Change from baseline in 9-item Patient Health Questionnaire (PHQ-9) score at the end of each 14-day treatment period in the DB Phase • Time to relapse during the DB phase (days; from first dose of study drug in DB Phase to relapse [date] during the DB Phase) for subjects who achieved HAM-D remission in the OL Phase • Incidence of TEAEs;Timepoint(s) of evaluation of this end point: At the end of each 14-day treatment period in the double blind phase, up to 233 Days; TEAE assessment is ongoing	—

Measure

Time frame

Secondary end point(s): Percentage of subjects who relapse during the DB Phase • Change from baseline in the 17-item HAM-D total score at the end of each 14-day treatment period in the DB Phase. • HAM-D response at the end of each 14-day treatment period in the DB Phase, defined as a =50% reduction in HAM-D score from baseline • HAM-D remission at the end of each 14-day treatment period in the DB Phase, defined as HAM-D total score =7 • CGI-I response, defined as “much improved” or “very much improved”, at the end of each 14-day treatment period in the DB Phase • Change from baseline in Clinical Global Impression - Severity (CGI-S) score at the end of each 14-day treatment period in the DB Phase Change from baseline in 9-item Patient Health Questionnaire (PHQ-9) score at the end of each 14-day treatment period in the DB Phase • Time to relapse during the DB phase (days; from first dose of study drug in DB Phase to relapse [date] during the DB Phase) for subjects who achieved HAM-D remission in the OL Phase • Incidence of TEAEs;Timepoint(s) of evaluation of this end point: At the end of each 14-day treatment period in the double blind phase, up to 233 Days; TEAE assessment is ongoing

—

Countries

Canada, Denmark, France, Germany, Spain, United Kingdom, United States

Contacts

Public ContactTimothy Mariano

Sage Therapeutics, Inc.

timothy.mariano@sagerx.com001617949-5588

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026