Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039022
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Types and rates of adverse events [ Time Frame: Up to 12 months ]
    Safety


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.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: Trial Manager 212-332-3241 ajones@axsome.com

Locations
Layout table for location information
United States, Florida
Axsome Study Site Recruiting
Jacksonville, Florida, United States, 32256
Contact: Study Coordinator         
Sponsors and Collaborators
Axsome Therapeutics, Inc.

Layout table for additonal information
Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04039022     History of Changes
Other Study ID Numbers: AXS-05-303
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
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