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

Clinical Trial ID: NCT04039022

Description

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

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.


Criteria

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

  • Start Date

    2019-07-08

  • Last Updated

    2019-08-22

  • Sponsor

    Axsome Therapeutics, Inc.

  • Condition Name

    Depression

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