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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
Last Update Posted : April 16, 2019
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

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety outcomes: types and rates of adverse events; discontinuations due to adverse events. [ Time Frame: 6 weeks ]

Other Outcome Measures:
  1. Montgomery and Asberg Depression Rating Scale (MADRS) for change in severity of symptoms. [ Time Frame: 6 weeks ]
  2. Clinical Global Impression of Severity of Illness (CGI-S) for change in severity of symptoms. [ Time Frame: 6 weeks ]
  3. Clinical Global Impression of Improvement of Illness (CGI-I) for change in improvement of disease state. [ Time Frame: 6 weeks ]
  4. Quick Inventory of Depressive Symptomology - Self-Rated (QIDS-SR-16) for change in subject-rated depressive symptomology. [ Time Frame: 6 weeks ]

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
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.
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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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
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

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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
 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