search
Back to results

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

Primary Purpose

Depression, Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AXS-05
Placebo
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AXS-05

Placebo

Arm Description

AXS-05 (bupropion and dextromethorphan) oral tablets

Placebo oral tablets to match AXS-05

Outcomes

Primary Outcome Measures

Change in MADRS Total Score From Baseline to Week 6
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.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2019
Last Updated
September 16, 2022
Sponsor
Axsome Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04019704
Brief Title
A Trial of AXS-05 in Patients With Major Depressive Disorder
Acronym
GEMINI
Official Title
AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
December 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Disorder
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXS-05
Arm Type
Experimental
Arm Description
AXS-05 (bupropion and dextromethorphan) oral tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablets to match AXS-05
Intervention Type
Drug
Intervention Name(s)
AXS-05
Intervention Description
Oral AXS-05 tablets, taken daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
Primary Outcome Measure Information:
Title
Change in MADRS Total Score From Baseline to Week 6
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Clinical Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Clinical Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Clinical Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Clinical Research Site
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Clinical Research Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Clinical Research Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Clinical Research Site
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Clinical Research Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Clinical Research Site
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Clinical Research Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Clinical Research Site
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Clinical Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Research Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Clinical Research Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Clinical Research Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Clinical Research Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Clinical Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clinical Research Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Clinical Research Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Clinical Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clinical Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Research Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Clinical Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Clinical Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Clinical Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Clinical Research Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Clinical Research Site
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Clinical Research Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Clinical Research Site
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Clinical Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Clinical Research Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Clinical Research Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Clinical Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Clinical Research Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Clinical Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Clinical Research Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Clinical Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Clinical Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Clinical Research Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Clinical Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Clinical Research Site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Clinical Research Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35649167
Citation
Iosifescu DV, Jones A, O'Gorman C, Streicher C, Feliz S, Fava M, Tabuteau H. Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI). J Clin Psychiatry. 2022 May 30;83(4):21m14345. doi: 10.4088/JCP.21m14345.
Results Reference
derived
PubMed Identifier
34510411
Citation
Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
Results Reference
derived
Links:
URL
http://www.axsome.com
Description
Axsome Therapeutics Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs