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

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ClinicalTrials.gov Identifier: NCT04019704
Recruitment Status : Completed
First Posted : July 15, 2019
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Brief Summary:
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

Condition or disease Intervention/treatment Phase
Depression Major Depressive Disorder Drug: AXS-05 Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
Actual Study Start Date : June 20, 2019
Actual Primary Completion Date : November 26, 2019
Actual Study Completion Date : December 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AXS-05
AXS-05 (bupropion and dextromethorphan) oral tablets
Drug: AXS-05
Oral AXS-05 tablets, taken daily for 6 weeks.

Placebo Comparator: Placebo
Placebo oral tablets to match AXS-05
Drug: Placebo
Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.




Primary Outcome Measures :
  1. Change in MADRS total score from baseline to Week 6 [ Time Frame: 6 weeks ]
    The Montgomery-Åsberg Depression Rating Scale (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.


Secondary Outcome Measures :
  1. Change in MADRS total score from baseline to Week 2 [ Time Frame: 2 weeks ]
  2. Percentage of subjects achieving remission (MADRS total score of ≤ 10) at Week 2 [ Time Frame: 2 weeks ]
  3. Change in MADRS total score from baseline to Week 1 [ Time Frame: 1 week ]
  4. Percentage of responders (≥50% reduction in MADRS total score) at Week 6 [ 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

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

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): NCT04019704


Locations
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United States, Arizona
Clinical Research Site
Phoenix, Arizona, United States, 85012
Clinical Research Site
Phoenix, Arizona, United States, 85016
United States, Arkansas
Clinical Research Site
Little Rock, Arkansas, United States, 72209
United States, California
Clinical Research Site
Bellflower, California, United States, 90706
Clinical Research Site
Beverly Hills, California, United States, 90210
Clinical Research Site
Garden Grove, California, United States, 92845
Clinical Research Site
Oakland, California, United States, 94607
Clinical Research Site
Oceanside, California, United States, 92056
Clinical Research Site
Panorama City, California, United States, 91402
Clinical Research Site
Redlands, California, United States, 92374
Clinical Research Site
Riverside, California, United States, 92506
Clinical Research Site
San Diego, California, United States, 92103
Clinical Research Site
Sherman Oaks, California, United States, 91403
Clinical Research Site
Upland, California, United States, 91786
United States, Florida
Clinical Research Site
Coral Springs, Florida, United States, 33067
Clinical Research Site
Hollywood, Florida, United States, 33024
Clinical Research Site
Jacksonville, Florida, United States, 32256
Clinical Research Site
Lauderhill, Florida, United States, 33319
Clinical Research Site
North Miami, Florida, United States, 33161
Clinical Research Site
Orlando, Florida, United States, 32801
United States, Georgia
Clinical Research Site
Atlanta, Georgia, United States, 30328
United States, Idaho
Clinical Research Site
Boise, Idaho, United States, 83704
United States, Illinois
Clinical Research Site
Chicago, Illinois, United States, 60634
United States, Massachusetts
Clinical Research Site
Boston, Massachusetts, United States, 02131
United States, Nevada
Clinical Research Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Clinical Research Site
Berlin, New Jersey, United States, 08009
Clinical Research Site
Cherry Hill, New Jersey, United States, 08002
Clinical Research Site
Toms River, New Jersey, United States, 08755
United States, New York
Clinical Research Site
Jamaica, New York, United States, 11432
Clinical Research Site
Rochester, New York, United States, 14618
Clinical Research Site
Staten Island, New York, United States, 10312
United States, North Carolina
Clinical Research Site
Hickory, North Carolina, United States, 28601
United States, Ohio
Clinical Research Site
Cincinnati, Ohio, United States, 45219
Clinical Research Site
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Clinical Research Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Clinical Research Site
Media, Pennsylvania, United States, 19063
Clinical Research Site
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Clinical Research Site
Memphis, Tennessee, United States, 38119
United States, Texas
Clinical Research Site
Dallas, Texas, United States, 75243
Clinical Research Site
Fort Worth, Texas, United States, 76104
Clinical Research Site
Houston, Texas, United States, 77058
Clinical Research Site
Wichita Falls, Texas, United States, 76309
United States, Washington
Clinical Research Site
Everett, Washington, United States, 98201
Sponsors and Collaborators
Axsome Therapeutics, Inc.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04019704    
Other Study ID Numbers: AXS-05-MDD-301
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
Depressive Disorder
Depressive Disorder, Major
Bupropion
Dextromethorphan
MDD
Dopamine Reuptake Inhibitor
AXS-05
NMDA Receptor Antagonist
Central Nervous System
CNS
Sigma-1 Receptor Agonist
Nicotinic Acetylcholine Receptor Antagonist
Norepinephrine Reuptake Inhibitor
Glutamate Modulator
Axsome Therapeutics
GEMINI
Serotonin Reuptake Inhibitor
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders