A Trial of AXS-05 in Patients With Major Depressive Disorder
GEMINI
AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
1 other identifier
interventional
327
1 country
43
Brief Summary
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 depression
Started Jun 2019
Shorter than P25 for phase_3 depression
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2019
CompletedFirst Submitted
Initial submission to the registry
July 11, 2019
CompletedFirst Posted
Study publicly available on registry
July 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2019
CompletedResults Posted
Study results publicly available
October 12, 2022
CompletedOctober 12, 2022
September 1, 2022
5 months
July 11, 2019
September 16, 2022
September 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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-Ă…sberg 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.
6 weeks
Study Arms (2)
AXS-05
EXPERIMENTALAXS-05 (bupropion and dextromethorphan) oral tablets
Placebo
PLACEBO COMPARATORPlacebo oral tablets to match AXS-05
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 - 65
- Currently meets DSM-5 criteria for MDD
- Body Mass Index between 18 and 40 kg/m\^2, inclusive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Clinical Research Site
Phoenix, Arizona, 85012, United States
Clinical Research Site
Phoenix, Arizona, 85016, United States
Clinical Research Site
Little Rock, Arkansas, 72209, United States
Clinical Research Site
Bellflower, California, 90706, United States
Clinical Research Site
Beverly Hills, California, 90210, United States
Clinical Research Site
Garden Grove, California, 92845, United States
Clinical Research Site
Oakland, California, 94607, United States
Clinical Research Site
Oceanside, California, 92056, United States
Clinical Research Site
Panorama City, California, 91402, United States
Clinical Research Site
Redlands, California, 92374, United States
Clinical Research Site
Riverside, California, 92506, United States
Clinical Research Site
San Diego, California, 92103, United States
Clinical Research Site
Sherman Oaks, California, 91403, United States
Clinical Research Site
Upland, California, 91786, United States
Clinical Research Site
Coral Springs, Florida, 33067, United States
Clinical Research Site
Hollywood, Florida, 33024, United States
Clinical Research Site
Jacksonville, Florida, 32256, United States
Clinical Research Site
Lauderhill, Florida, 33319, United States
Clinical Research Site
North Miami, Florida, 33161, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Atlanta, Georgia, 30328, United States
Clinical Research Site
Boise, Idaho, 83704, United States
Clinical Research Site
Chicago, Illinois, 60634, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
Las Vegas, Nevada, 89102, United States
Clinical Research Site
Berlin, New Jersey, 08009, United States
Clinical Research Site
Cherry Hill, New Jersey, 08002, United States
Clinical Research Site
Toms River, New Jersey, 08755, United States
Clinical Research Site
Jamaica, New York, 11432, United States
Clinical Research Site
Rochester, New York, 14618, United States
Clinical Research Site
Staten Island, New York, 10312, United States
Clinical Research Site
Hickory, North Carolina, 28601, United States
Clinical Research Site
Cincinnati, Ohio, 45219, United States
Clinical Research Site
Middleburg Heights, Ohio, 44130, United States
Clinical Research Site
Oklahoma City, Oklahoma, 73112, United States
Clinical Research Site
Media, Pennsylvania, 19063, United States
Clinical Research Site
Philadelphia, Pennsylvania, 19104, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Clinical Research Site
Dallas, Texas, 75243, United States
Clinical Research Site
Fort Worth, Texas, 76104, United States
Clinical Research Site
Houston, Texas, 77058, United States
Clinical Research Site
Wichita Falls, Texas, 76309, United States
Clinical Research Site
Everett, Washington, 98201, United States
Related Publications (2)
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.
PMID: 35649167DERIVEDDean 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.
PMID: 34510411DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Caroline Streicher, Senior Director, Clinical Operations
- Organization
- Axsome Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2019
First Posted
July 15, 2019
Study Start
June 20, 2019
Primary Completion
November 26, 2019
Study Completion
December 5, 2019
Last Updated
October 12, 2022
Results First Posted
October 12, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share