Trial · NCT04634669
Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)
NCT04634669, Phase 2, Terminated, Axsome Therapeutics, Inc.; results first posted 2026-01-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE). Trials, record NCT04634669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04634669
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 TRD (EVOLVE)
- NCT number
- NCT04634669
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 181 participants, actual
- Lead sponsor
- Axsome Therapeutics, Inc.
- Conditions
- Treatment Resistant Depression, Major Depressive Disorder
- Interventions
- AXS-05 (dextromethorphan-bupropion)
- First posted
- 2020-11-18
- Last updated
- 2026-01-28
- Results first posted
- 2026-01-28
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 | Duration of participation was up to 15 months. TEAEs were defined as any AE with an onset date in the interval between the first study treatment dosing date and 7 days after the last study treatment dosing date. |
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 | Duration of participation was up to 15 months. TEAEs were defined as any AE with an onset date in the interval between the first study treatment dosing date and 7 days after the last study treatment dosing date. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
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 | Subjects with any TEAEs | 112 | Participants | |
| Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | AXS-05 | Subjects with suspected to be drug-related TEAEs | 65 | Participants | |
| Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | AXS-05 | Subjects with serious TEAEs | 7 | Participants | |
| Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | AXS-05 | Subjects with TEAEs that led to drug withdrawal | 16 | Participants | |
| Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | AXS-05 | Subjects with TEAEs that led to withdrawal from study | 14 | Participants | |
| Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | AXS-05 | Subjects with TEAEs that resulted in death | 0 | 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 | 181 | |
| Overall Study | COMPLETED | AXS-05 | 11 | |
| Overall Study | NOT COMPLETED | AXS-05 | 170 |
Source ClinicalTrials.gov
Adverse events15
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 | Covid-19 | Infections and infestations | AXS-05 | 15 | 181 | 15 |
| other | Nausea | Gastrointestinal disorders | AXS-05 | 15 | 181 | 15 |
| other | Headache | Nervous system disorders | AXS-05 | 12 | 181 | 15 |
| serious | Inappropriate antidiuretic hormone secretion | Endocrine disorders | AXS-05 | 1 | 181 | 1 |
| serious | Cholecystitis | Hepatobiliary disorders | AXS-05 | 1 | 181 | 1 |
| serious | COVID-19 pneumonia | Infections and infestations | AXS-05 | 1 | 181 | 1 |
| serious | Coronavirus infection | Infections and infestations | AXS-05 | 1 | 181 | 1 |
| serious | Urinary tract infection | Infections and infestations | AXS-05 | 1 | 181 | 1 |
| serious | Procedural pain | Injury, poisoning and procedural complications | AXS-05 | 1 | 181 | 1 |
| serious | Hyponatraemia | Metabolism and nutrition disorders | AXS-05 | 1 | 181 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AXS-05 | 0 | 181 |
| Total, other adverse events | AXS-05 | 38 | 181 |
| Total, serious adverse events | AXS-05 | 7 | 181 |
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/NCT04634669
GET https://conductscience.org/api/trials/v1/NCT04634669/registered