A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

Biogen

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Matching Placebo; Drug: Sertraline; Drug: SAGE-217; Drug: Desvenlafaxine; Drug: Escitalopram; Drug: Duloxetine; Drug: Citalopram

Study type: Interventional

Funder types: Industry

Identifiers

NCT04476030

217-MDD-305

Details and patient eligibility

About

The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.

Full description

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

Enrollment: 440 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period
• 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score of ≥24 at Screening and Day 1
• Participant 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 is willing, able, and eligible to take at least 1 of the 5 ADTs specified in the protocol (an eligible ADT is an ADT that has not been taken during the current depressive episode and for which the participant has no contraindications; further, a participant is not eligible for citalopram if escitalopram has been taken during the current depressive episode, and vice versa)

Exclusion criteria

• Has attempted suicide associated with the current episode of MDD
• Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period
• Participant has treatment-resistant depression
• History of bipolar disorder, schizophrenia, and/or schizoaffective disorder
• Known allergy to SAGE-217, allopregnanolone, or related compounds
• Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine within 60 days prior to Day 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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440 participants in 2 patient groups

Placebo + Assigned ADT

Active Comparator group

Description:

Participants received SAGE-217-matching placebo capsules, orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily, from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.

Treatment:

Drug: Matching Placebo

Drug: Sertraline

Drug: Duloxetine

Drug: Citalopram

Drug: Desvenlafaxine

Drug: Escitalopram

SAGE-217 + Assigned ADT

Experimental group

Description:

Participants received SAGE-217, 50 milligrams (mg), orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.

Treatment:

Drug: Sertraline

Drug: Duloxetine

Drug: Citalopram

Drug: Desvenlafaxine

Drug: Escitalopram

Drug: SAGE-217