Open-Label Safety Study of AXS-05 in Subjects With Depression

Last updated: September 16, 2022
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Depression

Mood Disorders

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT04039022
AXS-05-303
  • Ages 18-65
  • All Genders

Study Summary

An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of major depressive disorder, including treatment resistant depression
  • Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
  • Agree to use adequate method of contraception for the duration of the study
  • Additional criteria may apply

Exclusion

Exclusion Criteria:

  • Suicide risk
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Additional criteria may apply

Study Design

Total Participants: 876
Study Start date:
July 08, 2019
Estimated Completion Date:
October 23, 2020

Study Description

A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one year.

Connect with a study center

  • Clinical Research Site

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Clinical Research Site

    Little Rock, Arkansas 72209
    United States

    Site Not Available

  • Clinical Research Site

    Bellflower, California 90706
    United States

    Site Not Available

  • Clinical Research Site

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Clinical Research Site

    Culver City, California 90230
    United States

    Site Not Available

  • Clinical Research Site

    Garden Grove, California 92845
    United States

    Site Not Available

  • Clinical Research Site

    Oakland, California 94607
    United States

    Site Not Available

  • Clinical Research Site

    Oceanside, California 92056
    United States

    Site Not Available

  • Clinical Research Site

    Panorama City, California 91402
    United States

    Site Not Available

  • Clinical Research Site

    Redlands, California 92374
    United States

    Site Not Available

  • Clinical Research Site

    San Diego, California 92103
    United States

    Site Not Available

  • Clinical Research Site

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Clinical Research Site

    Upland, California 91786
    United States

    Site Not Available

  • Clinical Research Site

    Cromwell, Connecticut 06416
    United States

    Site Not Available

  • Clinical Research Site

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Clinical Research Site

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Clinical Research Site

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Clinical Research Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Clinical Research Site

    Lauderhill, Florida 33319
    United States

    Site Not Available

  • Clinical Research Site

    Miami, Florida 33122
    United States

    Site Not Available

  • Clinical Research Site

    North Miami, Florida 33161
    United States

    Site Not Available

  • Clinical Research Site

    Orlando, Florida 32801
    United States

    Site Not Available

  • Clinical Research Site

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Clinical Research Site

    Boise, Idaho 83704
    United States

    Site Not Available

  • Clinical Research Site

    Chicago, Illinois 60634
    United States

    Site Not Available

  • Clinical Research Site

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Clinical Research Site

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Clinical Research Site

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Clinical Research Site

    Cherry Hill, New Jersey 08002
    United States

    Site Not Available

  • Clinical Research Site

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Clinical Research Site

    Jamaica, New York 11432
    United States

    Site Not Available

  • Clinical Research Site

    Rochester, New York 14618
    United States

    Site Not Available

  • Clinical Research Site

    Staten Island, New York 10312
    United States

    Site Not Available

  • Clinical Research Site

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Clinical Research Site

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Clinical Research Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Clinical Research Site

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Clinical Research Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Clinical Research Site

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Clinical Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Clinical Research Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Clinical Research Site

    Austin, Texas 78712
    United States

    Site Not Available

  • Clinical Research Site

    Dallas, Texas 75243
    United States

    Site Not Available

  • Clinical Research Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Clinical Research Site

    Houston, Texas 77058
    United States

    Site Not Available

  • Clinical Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Research Site

    Wichita Falls, Texas 76309
    United States

    Site Not Available

  • Clinical Research Site

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Clinical Research Site

    Everett, Washington 98201
    United States

    Site Not Available

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