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

Biogen

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: SAGE-217

Study type: Interventional

Funder types: Industry

Identifiers

NCT03864614

217-MDD-303

Details and patient eligibility

About

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.

Full description

This study was previously posted by Sage Therapeutics. In July 2024, sponsorship of the trial was transferred to Biogen.

Enrollment: 1,515 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,515 participants in 1 patient group

SAGE-217

Experimental group

Treatment:

Drug: SAGE-217