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

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ClinicalTrials.gov Identifier: NCT04039022

Recruitment Status : Recruiting

First Posted : July 31, 2019

Last Update Posted : August 26, 2019

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Axsome Therapeutics, Inc.

Study Description

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.

Study Design

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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

Genetics Home Reference related topics: Depression

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Types and rates of adverse events [ Time Frame: Up to 12 months ]
Safety

Other Outcome Measures:

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.

Eligibility Criteria

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

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

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Contact: Trial Manager	212-332-3241	ajones@axsome.com

Locations

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United States, Florida
Axsome Study Site	Recruiting
Jacksonville, Florida, United States, 32256
Contact: Study Coordinator

Sponsors and Collaborators

Axsome Therapeutics, Inc.

More Information

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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

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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

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