A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder

Biogen

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: SAGE-217

Study type: Interventional

Funder types: Industry

Identifiers

NCT03672175

217-MDD-301

Details and patient eligibility

About

This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).

Full description

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

Enrollment: 581 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant had a diagnosis of MDD with symptoms that had been present for at least a 4-week period.
2. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥32 and a 17-item Hamilton Rating Scale for Depression (HAM-D) total score ≥22 at screening and Day 1 (prior to dosing).

Exclusion criteria

1. Participant had active psychosis.
2. Participant had attempted suicide associated with the current episode of MDD.
3. Participant had 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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581 participants in 3 patient groups, including a placebo group

SAGE-217 Matched Placebo

Placebo Comparator group

Description:

Participants self-administered SAGE-217 matched placebo capsules, orally, once daily in the evening with food for 14 days.

Treatment:

Drug: Placebo

SAGE-217 20 mg

Experimental group

Description:

Participants self-administered SAGE-217 20 milligrams (mg) capsules, orally, once daily in the evening with food for 14 days.

Treatment:

Drug: SAGE-217

SAGE-217 30 mg

Experimental group

Description:

Participants self-administered SAGE-217 30 mg capsules, orally, once daily in the evening with food for 14 days.

Treatment:

Drug: SAGE-217