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A Trial of AXS-05 in Patients With Major Depressive Disorder (GEMINI)

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: NCT04019704
Recruitment Status : Completed
First Posted : July 15, 2019
Results First Posted : October 12, 2022
Last Update Posted : October 12, 2022
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 15, 2019
Results First Submitted Date  ICMJE September 16, 2022
Results First Posted Date  ICMJE October 12, 2022
Last Update Posted Date October 12, 2022
Actual Study Start Date  ICMJE June 20, 2019
Actual Primary Completion Date November 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2022)
Change in MADRS Total Score From Baseline to Week 6 [ Time Frame: 6 weeks ]
The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • Safety outcomes: types and rates of adverse events [ Time Frame: 6 weeks ]
  • Efficacy outcomes: Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]
    For assessment of depressive symptomatology.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Trial of AXS-05 in Patients With Major Depressive Disorder
Official Title  ICMJE AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
Brief Summary A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
Detailed Description This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Major Depressive Disorder
Intervention  ICMJE
  • Drug: AXS-05
    Oral AXS-05 tablets, taken daily for 6 weeks.
  • Drug: Placebo
    Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
Study Arms  ICMJE
  • Experimental: AXS-05
    AXS-05 (bupropion and dextromethorphan) oral tablets
    Intervention: Drug: AXS-05
  • Placebo Comparator: Placebo
    Placebo oral tablets to match AXS-05
    Intervention: Drug: Placebo
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2019)
Actual Study Completion Date  ICMJE December 5, 2019
Actual Primary Completion Date November 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Age 18 - 65
  • Currently meets DSM-5 criteria for MDD
  • Body Mass Index between 18 and 40 kg/m^2, inclusive

Key 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
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04019704
Other Study ID Numbers  ICMJE AXS-05-MDD-301
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
Current Responsible Party Axsome Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Axsome Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Axsome Therapeutics, Inc.
Verification Date September 2022

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