Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
NCT06223880

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

Led by Axsome Therapeutics, Inc. · Updated on 2025-01-23

350

Participants Needed

40

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.

CONDITIONS

Official Title

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
  • Current major depressive episode of at least 4 weeks in duration
Not Eligible

You will not qualify if you...

  • Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of Screening Visit 1, or has been prescribed Auvelity
  • Unable to comply with study procedures
  • Medically inappropriate for study participation in the opinion of the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 40 locations

1

Clinical Research Site

Bellflower, California, United States, 90706

Actively Recruiting

2

Clinical Research Site

Lafayette, California, United States, 94549

Actively Recruiting

3

Clinical Research Site

Oceanside, California, United States, 92056

Actively Recruiting

4

Clinical Research Site

Redlands, California, United States, 92374

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5

Clinical Research Site

Riverside, California, United States, 92506

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6

Clinical Research Site

San Diego, California, United States, 92103

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7

Clinical Research Site

Upland, California, United States, 91786

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8

Clinical Research Site

Brandon, Florida, United States, 33511

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9

Clinical Research Site

Doral, Florida, United States, 33122

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10

Clinical Research Site

Hialeah, Florida, United States, 33012

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11

Clinical Research Site

Jacksonville, Florida, United States, 32256

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12

Clinical Research Site

Miami, Florida, United States, 33122

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13

Clinical Research Site

Orlando, Florida, United States, 32801

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14

Clinical Research Site

Orlando, Florida, United States, 32806

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15

Clinical Research Site

Orlando, Florida, United States, 32807

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16

Clinical Research Site

Atlanta, Georgia, United States, 30331

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17

Clinical Research Site

Chicago, Illinois, United States, 60634

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18

Clinical Research Site

Overland Park, Kansas, United States, 66210

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19

Clinical Research Site

New Orleans, Louisiana, United States, 70115

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20

Clinical Research Site

Boston, Massachusetts, United States, 02131

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21

Clinical Research Site

Saint Charles, Missouri, United States, 63304

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22

Clinical Research Site

Las Vegas, Nevada, United States, 89102

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23

Clinical Research Site

Cherry Hill, New Jersey, United States, 08002

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24

Clinical Research Site

Toms River, New Jersey, United States, 08755

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25

Clinical Research Site

Brooklyn, New York, United States, 11235

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26

Clinical Research Site

Mount Kisco, New York, United States, 10549

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27

Clinical Research Site

New York, New York, United States, 10128

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28

Clinical Research Site

Staten Island, New York, United States, 10314

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29

Clinical Research Site

Hickory, North Carolina, United States, 28601

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30

Clinical Research Site

Cincinnati, Ohio, United States, 45215

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31

Clinical Research Site

Edmond, Oklahoma, United States, 73013

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32

Clinical Research Site

Oklahoma City, Oklahoma, United States, 73118

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33

Clinical Research Site

Portland, Oregon, United States, 97210

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34

Clinical Research Site

Memphis, Tennessee, United States, 38119

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35

Clinical Research Site

Dallas, Texas, United States, 75231

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36

Clinical Research Site

Dallas, Texas, United States, 75243

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37

Clinical Research Site

Friendswood, Texas, United States, 77546

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38

Clinical Research Site

San Antonio, Texas, United States, 78229

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39

Clinical Research Site

Wichita Falls, Texas, United States, 76309

Actively Recruiting

40

Clinical Research Site

Everett, Washington, United States, 98201

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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