A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder

Biogen

Status and phase: Completed; Phase 2

Conditions: Major Depression

Treatments: Drug: SAGE-217; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03000530

217-MDD-201

Details and patient eligibility

About

This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.

Full description

Part A of the study is an open-label design with dosing of SAGE-217 for 14 days.

Part B of the study is a randomized, double-blind, parallel-group, placebo-controlled design. Eligible participants were randomized to SAGE-217 or placebo for 14 days.

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Enrollment: 102 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has a diagnosis of Major Depressive Disorder that has been present for at least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)

Exclusion criteria

• Participant has a history of suicide attempt
• Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time
• Participant has active psychosis
• Participant has a medical history of seizures
• Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 3 patient groups, including a placebo group

Part A: SAGE-217

Experimental group

Description:

Participants received SAGE-217, 30 milligrams (mg), oral solution, once daily for 14 days, as tolerated.

Treatment:

Drug: SAGE-217

Part B: Placebo

Placebo Comparator group

Description:

Eligible participants received matching placebo capsules once daily for 14 days.

Treatment:

Drug: Placebo

Part B: SAGE-217

Experimental group

Description:

Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days.

Treatment:

Drug: SAGE-217