8 completed, 2 recruiting, 1 unknown. 6 Phase 2, 5 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 4, Recruiting 1, Unknown 1 |
| Phase 3 | 5 | Completed 5 |
| Phase 4 | 1 | Recruiting 1 |
Follow AXS-05: new trials by email Literature Review of AXS-05 trials Research Report on AXS-05
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Dextromethorphan-Bupropion on Striatal Activity in Adults With Major Depressive Disorder Dextromethorphan-Bupropion - Major Depressive Disorder (MDD) | Phase 2 | Recruiting | Roger McIntyre | 30 | 2025-11-21 | 2026-04-13 |
| A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms AXS-05, Bupropion - Major Depressive Disorder | Phase 4 | Recruiting | Axsome Therapeutics, Inc. | 350 | 2023-12-27 | 2025-01-23 |
| A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation AXS-05, Placebo - Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease | Phase 3 | Completed | Axsome Therapeutics, Inc. | 408 | 2022-09-06 | 2026-08-13 |
| An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients AXS-05, Bupropion SR - Major Depressive Disorder, Treatment Resistant Depression | Phase 2 | Unknown | Axsome Therapeutics, Inc. | 312 | 2021-04-14 | 2021-07-26 |
| Assessing Clinical Outcomes in Alzheimer's Disease Agitation AXS-05, Placebo - Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease | Phase 3 | Completed | Axsome Therapeutics, Inc. | 178 | 2020-12-31 | 2023-11-29 |
| Mechanistic Evaluation of Response in TRD (MERIT) AXS-05, Placebo - Treatment Resistant Depression, Major Depressive Disorder | Phase 2 | Completed | Axsome Therapeutics, Inc. | 44 | 2020-08-13 | 2022-07-12 |
| A Trial of AXS-05 in Patients With Major Depressive Disorder AXS-05, Placebo - Depression, Major Depressive Disorder | Phase 3 | Completed | Axsome Therapeutics, Inc. | 327 | 2019-06-20 | 2022-10-12 |
| Assessing Symptomatic Clinical Episodes in Depression AXS-05, Bupropion - Major Depressive Disorder | Phase 2 | Completed | Axsome Therapeutics, Inc. | 97 | 2018-05-30 | 2021-09-24 |
| AXS-05 Phase II Trial on Smoking Behavior AXS-05, Bupropion SR - Smoking Cessation, Smoking, Cigarette | Phase 2 | Completed | James Davis | 58 | 2018-03-25 | 2022-12-19 |
| Addressing Dementia Via Agitation-Centered Evaluation AXS-05, Bupropion, Placebo - Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease | Phase 2 / Phase 3 | Completed | Axsome Therapeutics, Inc. | 366 | 2017-07-13 | 2023-09-13 |
| A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder AXS-05, Bupropion - Treatment Resistant Major Depressive Disorder | Phase 3 | Completed | Axsome Therapeutics, Inc. | 312 | 2016-03-01 | 2021-03-24 |
Depressive Disorder, Major (7) · Depression (5) · Alzheimer Disease (3) · Depressive Disorder, Treatment-Resistant (3) · Psychomotor Agitation (3) · Cigarette Smoking (1) · Depressive Disorder (1) · Smoking Cessation (1) · Tobacco Use Disorder (1)
Axsome Therapeutics, Inc. (9) · James Davis (1) · Roger McIntyre (1)
United States (10) · Canada (2) · Australia (1) · Puerto Rico (1)