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

Phase 1

Active, not recruiting

• Conditions: MAJOR DEPRESSIVE DISORDER; MedDRA version: 21.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-002640-25-GB
• Lead Sponsor: Sage Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-08
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 546

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>