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A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder

NCT02741791 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2021-03-24

No results posted yet for this study

Summary

To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD).

This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD.

Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.

Conditions

  • Treatment Resistant Major Depressive Disorder

Interventions

DRUG

AXS-05

AXS-05 taken daily for 6 weeks.

DRUG

Bupropion

Buproprion taken daily for 6 weeks.

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-03-20
Completion
2020-03-20

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT02741791 on ClinicalTrials.gov