Open-Label Safety Study of AXS-05 in Subjects With Depression
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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 |
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Recruitment Status :
Completed
First Posted : July 31, 2019
Results First Posted : October 12, 2022
Last Update Posted : October 12, 2022
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Sponsor:
Axsome Therapeutics, Inc.
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.
- Study Details
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- Study Results
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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 |
| 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
MedlinePlus Genetics related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
| Experimental: AXS-05 |
Drug: AXS-05 (dextromethorphan and bupropion) oral tablets
Oral tablets, taken twice daily for up to 12 months. |
Primary Outcome Measures :
- Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 [ Time Frame: Up to 12 months ]Types and rates of adverse events
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
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
Show 51 study locations
Sponsors and Collaborators
Axsome Therapeutics, Inc.
Study Documents (Full-Text)
Documents provided by Axsome Therapeutics, Inc.:
Documents provided by Axsome Therapeutics, Inc.:
Study Protocol and Statistical Analysis Plan [PDF] July 9, 2020
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Axsome Therapeutics, Inc.:
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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 Levomethorphan 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 Analgesics, Opioid Narcotics Central Nervous System Depressants |