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

NCT04476030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2023-12-22

Study results available
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Summary

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.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

SAGE-217

Oral capsules

DRUG

Matching Placebo

Oral capsules

DRUG

Sertraline

Oral tablets

DRUG

Escitalopram

Oral tablets

DRUG

Citalopram

Oral tablets

DRUG

Duloxetine

Oral capsules

DRUG

Desvenlafaxine

Oral tablets

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2021-10-25
Completion
2021-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04476030 on ClinicalTrials.gov