Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
366 participants
INTERVENTIONAL
2017-07-13
2020-04-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
NCT04947553
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
NCT04797715
An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study
NCT06736509
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
NCT05557409
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
NCT02817906
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AXS-05
AXS-05 tablets taken by mouth for 5 weeks.
AXS-05
AXS-05
Bupropion
Bupropion tablets taken by mouth for 5 weeks.
Bupropion
Bupropion
Placebo
Placebo tablets taken by mouth for 5 weeks.
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AXS-05
AXS-05
Bupropion
Bupropion
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of clinically signification agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.
Exclusion Criteria
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.
65 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Axsome Study Site
Gilbert, Arizona, United States
Axsome Study Site
Phoenix, Arizona, United States
Axsome study site
Scottsdale, Arizona, United States
Axsome study site
Scottsdale, Arizona, United States
Axsome Study Site
Tucson, Arizona, United States
Axsome Study Site
Little Rock, Arkansas, United States
Axsome study site
Canoga Park, California, United States
Axsome study site
Costa Mesa, California, United States
Axsome study site
Fresno, California, United States
Axsome study site
Long Beach, California, United States
Axsome study site
Long Beach, California, United States
Axsome Study Site
Los Alamitos, California, United States
Axsome study site
Riverside, California, United States
Axsome study site
Sacramento, California, United States
Axsome study site
Santa Ana, California, United States
Axsome Study Site
Santa Clarita, California, United States
Axsome study site
Sherman Oaks, California, United States
Axsome study site
Simi Valley, California, United States
Axsome study site
Temecula, California, United States
Axsome study site
Ventura, California, United States
Axsome Study Site
Colorado Springs, Colorado, United States
Axsome study site
Cromwell, Connecticut, United States
Axsome study site
New London, Connecticut, United States
Axsome Study Site
Apopka, Florida, United States
Axsome study site
Boca Raton, Florida, United States
Axsome study site
Boynton Beach, Florida, United States
Axsome Study Site
Coconut Creek, Florida, United States
Axsome Study Site
Greenacres City, Florida, United States
Axsome study site
Hallandale, Florida, United States
Axsome study site
Hialeah, Florida, United States
Axsome Study Site
Lake City, Florida, United States
Axsome study site
Miami, Florida, United States
Axsome study site
Miami, Florida, United States
Axsome Study Site
Orlando, Florida, United States
Axsome study site
Pensacola, Florida, United States
Axsome Study Site
Port Orange, Florida, United States
Axsome study site
Spring Hill, Florida, United States
Axsome study site
Tampa, Florida, United States
Axsome study site
Tampa, Florida, United States
Axsome study site
Atlanta, Georgia, United States
Axsome study site
Decatur, Georgia, United States
Axsome Study Site
Honolulu, Hawaii, United States
Axsome study site
Boise, Idaho, United States
Axsome Study Site
Flossmoor, Illinois, United States
Axsome study site
Avon, Indiana, United States
Axsome Study Site
Overland Park, Kansas, United States
Axsome Study Site
Topeka, Kansas, United States
Axsome study site
Baton Rouge, Louisiana, United States
Axsome Study Site
Lake Charles, Louisiana, United States
Axsome Study Site
Hattiesburg, Mississippi, United States
Axsome study site
Chesterfield, Missouri, United States
Axsome Study Site
St Louis, Missouri, United States
Axsome study site
Las Vegas, Nevada, United States
Axsome Study Site
Las Vegas, Nevada, United States
Axsome Study Site
Princeton, New Jersey, United States
Axsome study site
Toms River, New Jersey, United States
Axsome Study Site
Albany, New York, United States
Axsome study site
Brooklyn, New York, United States
Axsome study site
New York, New York, United States
Axsome study site
New York, New York, United States
Axsome study site
Staten Island, New York, United States
Axsome Study Site
Charlotte, North Carolina, United States
Axsome study site
Charlotte, North Carolina, United States
Axsome Study Site
Winston-Salem, North Carolina, United States
Axsome study site
Cincinnati, Ohio, United States
Axsome Study Site
Dayton, Ohio, United States
Axsome study site
Shaker Heights, Ohio, United States
Axsome Study Site
Oklahoma City, Oklahoma, United States
Axsome study site
DeSoto, Texas, United States
Axsome Study Site
McKinney, Texas, United States
Axsome study site
Wichita Falls, Texas, United States
Axsome study site
Orem, Utah, United States
Axsome Study Site
Charlottesville, Virginia, United States
Axsome Study Site
Richmond, Virginia, United States
Axsome study site
Bellevue, Washington, United States
Axsome Study Site
Everett, Washington, United States
Axsome study site
Spokane, Washington, United States
Axsome study site
Caulfield, Melbourne, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Axsome Therapeutics Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AXS-05-AD-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.