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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039022
Recruitment Status : Completed
First Posted : July 31, 2019
Results First Posted : October 12, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Treatment Resistant Depression Depression Drug: AXS-05 (dextromethorphan and bupropion) oral tablets Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 876 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 Major Depressive Disorder
Actual Study Start Date : July 8, 2019
Actual Primary Completion Date : October 23, 2020
Actual Study Completion Date : October 23, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AXS-05 Drug: AXS-05 (dextromethorphan and bupropion) oral tablets
Oral tablets, taken twice daily for up to 12 months.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 [ Time Frame: Up to 12 months ]
    Types and rates of adverse events


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04039022


Locations
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Sponsors and Collaborators
Axsome Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Axsome Therapeutics, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] July 9, 2020

More Information
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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04039022    
Other Study ID Numbers: AXS-05-303
First Posted: July 31, 2019    Key Record Dates
Results First Posted: October 12, 2022
Last Update Posted: October 12, 2022
Last Verified: September 2022
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
Keywords provided by Axsome Therapeutics, Inc.:
Depression
AXS-05
Dextromethorphan
Bupropion
Dopamine Reuptake Inhibitor
NMDA Receptor Antagonist
Nicotinic Acetylcholine Receptor Antagonist
 Serotonin Reuptake Inhibitor
Axsome Therapeutics
Norepinephrine Reuptake Inhibitor
Sigma-1 Receptor Agonist
Glutamate Modulator
Antidepressant
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dextromethorphan
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents