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Assessing Symptomatic Clinical Episodes in Depression (ASCEND)

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: NCT03595579
Recruitment Status : Completed
First Posted : July 23, 2018
Results First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Study Description
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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

Detailed Description:
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 Design
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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


Arms and Interventions
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Arm Intervention/treatment
Experimental: AXS-05 Drug: AXS-05
AXS-05 taken twice daily for 6 weeks.
Active Comparator: Bupropion Drug: Bupropion
Bupropion taken twice daily for 6 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. MADRS Score - Overall Change From Baseline [ Time Frame: Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period) ]
    The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.


Other Outcome Measures:
  1. MADRS Score - Change From Baseline to Week 6 [ Time Frame: 6 weeks ]
    The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.


Eligibility Criteria
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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
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): NCT03595579


Locations
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United States, California
Clinical Research Site
Beverly Hills, California, United States, 90210
United States, Florida
Clinical Research Site
Jacksonville, Florida, United States, 32256
Clinical Research Site
Orlando, Florida, United States, 32801
United States, Washington
Clinical Research Site
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Axsome Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Axsome Therapeutics, Inc.:
Study Protocol  [PDF] June 28, 2018
Statistical Analysis Plan  [PDF] December 11, 2018

More Information
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Additional Information:

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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03595579    
Other Study ID Numbers: AXS-05-MDD-201
First Posted: July 23, 2018    Key Record Dates
Results First Posted: September 24, 2021
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: via publication

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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.:
AXS-05
Major Depressive Disorder
MDD
Axsome
Depression
 Dextromethorphan
Bupropion
Sigma-1
NDMA
ASCEND
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