Trial · NCT04039022
Open-Label Safety Study of AXS-05 in Subjects With Depression
NCT04039022, Phase 3, Completed, Axsome Therapeutics, Inc.; results first posted 2022-10-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Safety Study of AXS-05 in Subjects With Depression. Trials, record NCT04039022. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04039022
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Safety Study of AXS-05 in Subjects With Depression
- NCT number
- NCT04039022
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 876 participants, actual
- Lead sponsor
- Axsome Therapeutics, Inc.
- Conditions
- Major Depressive Disorder, Treatment Resistant Depression, Depression
- Interventions
- AXS-05 (dextromethorphan and bupropion) oral tablets
- First posted
- 2019-07-31
- Last updated
- 2022-10-12
- Results first posted
- 2022-10-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | Up to 12 months | Types and rates of adverse events |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | Up to 12 months | Primary Safety Population (subjects who continued beyond Week 6 of the trial) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | AXS-05 | 505 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AXS-05 | 876 | |
| Overall Study | COMPLETED | AXS-05 | 53 | |
| Overall Study | NOT COMPLETED | AXS-05 | 823 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | AXS-05 | 111 | 876 | 117 |
| other | Nausea | Gastrointestinal disorders | AXS-05 | 104 | 876 | 110 |
| other | Headache | Nervous system disorders | AXS-05 | 77 | 876 | 84 |
| other | Dry mouth | Gastrointestinal disorders | AXS-05 | 62 | 876 | 64 |
| other | Decreased appetite | Metabolism and nutrition disorders | AXS-05 | 53 | 876 | 53 |
| other | Constipation | Gastrointestinal disorders | AXS-05 | 29 | 876 | 29 |
| other | Diarrhea | Gastrointestinal disorders | AXS-05 | 33 | 876 | 37 |
| other | Nasopharyngitis | Infections and infestations | AXS-05 | 39 | 876 | 41 |
| other | Upper respiratory tract infection | Infections and infestations | AXS-05 | 35 | 876 | 42 |
| other | Somnolence | Nervous system disorders | AXS-05 | 30 | 876 | 33 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AXS-05 | 2 | 876 |
| Total, other adverse events | AXS-05 | 609 | 876 |
| Total, serious adverse events | AXS-05 | 21 | 876 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04039022
GET https://conductscience.org/api/trials/v1/NCT04039022/events?page=2