Assessing Symptomatic Clinical Episodes in Depression (ASCEND)
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| ClinicalTrials.gov Identifier: NCT03595579 |
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Recruitment Status :
Completed
First Posted : July 23, 2018
Last Update Posted : April 16, 2019
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Sponsor:
Axsome Therapeutics, Inc.
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.
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Brief Summary:
Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depressive Disorder | Drug: AXS-05 Drug: Bupropion | Phase 2 |
This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 97 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder |
| Actual Study Start Date : | May 30, 2018 |
| Actual Primary Completion Date : | January 7, 2019 |
| Actual Study Completion Date : | January 7, 2019 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
| Experimental: AXS-05 |
Drug: AXS-05
AXS-05 taken daily for 6 weeks. |
| Active Comparator: Bupropion |
Drug: Bupropion
Bupropion taken daily for 6 weeks. |
Primary Outcome Measures :
- Safety outcomes: types and rates of adverse events; discontinuations due to adverse events. [ Time Frame: 6 weeks ]
Other Outcome Measures:
- Montgomery and Asberg Depression Rating Scale (MADRS) for change in severity of symptoms. [ Time Frame: 6 weeks ]
- Clinical Global Impression of Severity of Illness (CGI-S) for change in severity of symptoms. [ Time Frame: 6 weeks ]
- Clinical Global Impression of Improvement of Illness (CGI-I) for change in improvement of disease state. [ Time Frame: 6 weeks ]
- Quick Inventory of Depressive Symptomology - Self-Rated (QIDS-SR-16) for change in subject-rated depressive symptomology. [ Time Frame: 6 weeks ]
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:
- Currently meets DSM-5 criteria for MDD
- 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
- History of treatment resistance in current depressive episode
- History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
- 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): NCT03595579
Locations
| United States, California | |
| Axsome Study Site | |
| Beverly Hills, California, United States, 90210 | |
| United States, Florida | |
| Axsome Study Site | |
| Jacksonville, Florida, United States, 32256 | |
| Axsome Study Site | |
| Orlando, Florida, United States, 32801 | |
| United States, Washington | |
| Axsome Study Site | |
| Bellevue, Washington, United States, 98007 | |
Sponsors and Collaborators
Axsome Therapeutics, Inc.
Additional Information:
| Responsible Party: | Axsome Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03595579 History of Changes |
| Other Study ID Numbers: |
AXS-05-MDD-201 |
| First Posted: | July 23, 2018 Key Record Dates |
| Last Update Posted: | April 16, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | via publication |
| 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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AXS-05 Major Depressive Disorder MDD Axsome |
NMDA Receptor Depression Dextromethorphan Bupropion |
Additional relevant MeSH terms:
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Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms 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 |