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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04634669
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Brief Summary:
This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with treatment resistant depression (TRD).

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Major Depressive Disorder Drug: AXS-05 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Treatment Resistant Depression
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AXS-05 Drug: AXS-05
- AXS-05 tablet, taken daily (up to 12 months)

Primary Outcome Measures :
  1. Incidence of treatment-emergent AEs (TEAEs) following dosing with AXS-05 [ Time Frame: Up to 12 months ]

Other Outcome Measures:
  1. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Up to 12 months ]
    The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Continued depression despite treatment with antidepressants in the current depressive episode
  • Agree to use adequate method of contraception for the duration of the study
  • Additional criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04634669

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Contact: Study Director 212-332-3241

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United States, Florida
AXS-05-TRD-202 Site Recruiting
Orlando, Florida, United States, 32081
Sponsors and Collaborators
Axsome Therapeutics, Inc.
Additional Information:
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Responsible Party: Axsome Therapeutics, Inc. Identifier: NCT04634669    
Other Study ID Numbers: AXS-05-TRD-202
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Axsome Therapeutics, Inc.:
Treatment Resistant Depression
NMDA receptor
Refractory depression
Resistant depression
Major depression
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders