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Trial record 1 of 12 for:    Axsome
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Open-Label Safety Study of AXS-05 in Subjects With Depression

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039022
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 29, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE July 8, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
Types and rates of adverse events [ Time Frame: Up to 12 months ]
Safety
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 22, 2019)
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.
Original Other Pre-specified Outcome Measures
 (submitted: July 29, 2019)
Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Up to 12 months ]
Efficacy outcome for assessment of depressive symptomatology.
 
Descriptive Information
Brief Title  ICMJE Open-Label Safety Study of AXS-05 in Subjects With Depression
Official Title  ICMJE An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder
Brief Summary An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Treatment Resistant Depression
  • Depression
Intervention  ICMJE Drug: AXS-05
Oral tablets, taken twice daily for up to 12 months.
Study Arms  ICMJE Experimental: AXS-05 (dextromethorphan and bupropion)
Intervention: Drug: AXS-05
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 29, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Manager 212-332-3241 ajones@axsome.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04039022
Other Study ID Numbers  ICMJE AXS-05-303
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Axsome Therapeutics, Inc.
Study Sponsor  ICMJE Axsome Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Axsome Therapeutics, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP