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Showing 1–15 of 15 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: AXS-05 Clear all
Completed Phase 3 Interventional

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

NCT04797715
View directory record Official record
Conditions
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
Interventions
AXS-05, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
65 Years to 90 Years
Enrollment
178 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
61
States / cities
Sun City, Arizona • Tucson, Arizona • Chula Vista, California + 55 more
Source: ClinicalTrials.gov public record
Updated Nov 28, 2023 · Synced Sep 1, 2026, 1:43 PM EDT
Completed Phase 3 Interventional Results available

Open-Label Safety Study of AXS-05 in Subjects With Depression

NCT04039022
View directory record Official record
Conditions
Major Depressive Disorder, Treatment Resistant Depression, Depression
Interventions
AXS-05 (dextromethorphan and bupropion) oral tablets
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
876 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
51
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Bellflower, California + 46 more
Source: ClinicalTrials.gov public record
Updated Oct 11, 2022 · Synced Sep 1, 2026, 1:43 PM EDT
Not listed Phase 2 Interventional

An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients

NCT04971291
View directory record Official record
Conditions
Major Depressive Disorder, Treatment Resistant Depression
Interventions
AXS-05, Bupropion SR
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
312 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jul 25, 2021 · Synced Sep 1, 2026, 1:43 PM EDT
Completed Phase 3 Interventional Results available

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

NCT04019704
View directory record Official record
Conditions
Depression, Major Depressive Disorder
Interventions
AXS-05, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
327 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
43
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Bellflower, California + 39 more
Source: ClinicalTrials.gov public record
Updated Oct 11, 2022 · Synced Sep 1, 2026, 1:43 PM EDT
Recruiting Phase 3 Interventional

A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults

NCT07766655
View directory record Official record
Conditions
Smoking Cessation
Interventions
AXS-05 (dextromethorphan-bupropion), Bupropion, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
705 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
9
States / cities
Little Rock, Arkansas • Jacksonville, Florida • Orlando, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2026 · Synced Sep 1, 2026, 1:43 PM EDT
Terminated Phase 2 Interventional Results available

Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)

NCT04634669
View directory record Official record
Conditions
Treatment Resistant Depression, Major Depressive Disorder
Interventions
AXS-05 (dextromethorphan-bupropion)
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
181 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
20
States / cities
Little Rock, Arkansas • Redlands, California • Sherman Oaks, California + 17 more
Source: ClinicalTrials.gov public record
Updated Jan 27, 2026 · Synced Sep 1, 2026, 1:43 PM EDT
Completed Phase 3 Interventional

A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder

NCT02741791
View directory record Official record
Conditions
Treatment Resistant Major Depressive Disorder
Interventions
AXS-05, Bupropion
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
312 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
74
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Anaheim, California + 71 more
Source: ClinicalTrials.gov public record
Updated Mar 23, 2021 · Synced Sep 1, 2026, 1:43 PM EDT
Completed Phase 2 Interventional

Mechanistic Evaluation of Response in TRD (MERIT)

NCT04608396
View directory record Official record
Conditions
Treatment Resistant Depression, Major Depressive Disorder
Interventions
AXS-05, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
20
States / cities
Little Rock, Arkansas • Redlands, California • Sherman Oaks, California + 17 more
Source: ClinicalTrials.gov public record
Updated Jul 11, 2022 · Synced Sep 1, 2026, 1:43 PM EDT
Completed Phase 2 Interventional Results available

Assessing Symptomatic Clinical Episodes in Depression

NCT03595579
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
AXS-05, Bupropion
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
97 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
4
States / cities
Beverly Hills, California • Jacksonville, Florida • Orlando, Florida + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 23, 2021 · Synced Sep 1, 2026, 1:43 PM EDT
Completed Phase 3 Interventional Results available

A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation

NCT05557409
View directory record Official record
Conditions
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation
Interventions
AXS-05, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
65 Years to 90 Years
Enrollment
408 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
53
States / cities
Peoria, Arizona • Tempe, Arizona • Tucson, Arizona + 43 more
Source: ClinicalTrials.gov public record
Updated Aug 12, 2026 · Synced Sep 1, 2026, 1:43 PM EDT
Completed Phase 2Phase 3 Interventional Results available

Addressing Dementia Via Agitation-Centered Evaluation

NCT03226522
View directory record Official record
Conditions
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
Interventions
AXS-05, Bupropion, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
65 Years to 90 Years
Enrollment
366 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
77
States / cities
Gilbert, Arizona • Phoenix, Arizona • Scottsdale, Arizona + 67 more
Source: ClinicalTrials.gov public record
Updated Sep 12, 2023 · Synced Sep 1, 2026, 1:43 PM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

AXS-05 Phase II Trial on Smoking Behavior

NCT03471767
View directory record Official record
Conditions
Smoking Cessation, Smoking, Cigarette, Nicotine Dependence
Interventions
AXS-05, Bupropion SR
Drug
Lead sponsor
James Davis
Other
Eligibility
18 Years and older
Enrollment
58 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2019
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Dec 18, 2022 · Synced Sep 1, 2026, 1:43 PM EDT
Completed Phase 3 Interventional

A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

NCT04947553
View directory record Official record
Conditions
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor
Interventions
AXS-05 (dextromethorphan-bupropion), Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
65 Years to 90 Years
Enrollment
456 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
45
States / cities
Peoria, Arizona • Tempe, Arizona • Long Beach, California + 35 more
Source: ClinicalTrials.gov public record
Updated Dec 7, 2025 · Synced Sep 1, 2026, 1:43 PM EDT
Recruiting Phase 4 Interventional

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

NCT06223880
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
AXS-05, Bupropion
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
350 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
40
States / cities
Bellflower, California • Lafayette, California • Oceanside, California + 34 more
Source: ClinicalTrials.gov public record
Updated Jan 22, 2025 · Synced Sep 1, 2026, 1:43 PM EDT
Terminated Phase 3 Interventional Results available

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
View directory record Official record
Conditions
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor
Interventions
AXS-05 (dextromethorphan-bupropion)
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
65 Years to 90 Years
Enrollment
139 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
21
States / cities
Peoria, Arizona • Walnut Creek, California • Bonita Springs, Florida + 13 more
Source: ClinicalTrials.gov public record
Updated Jun 24, 2026 · Synced Sep 1, 2026, 1:43 PM EDT