Trial · NCT04019704

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

NCT04019704, 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. A Trial of AXS-05 in Patients With Major Depressive Disorder. Trials, record NCT04019704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04019704

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial of AXS-05 in Patients With Major Depressive Disorder
NCT number: NCT04019704
Status: Completed
Phases: Phase 3
Enrollment: 327 participants, actual
Lead sponsor: Axsome Therapeutics, Inc.
Conditions: Depression, Major Depressive Disorder
Interventions: AXS-05, Placebo
First posted: 2019-07-15
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	Change in MADRS Total Score From Baseline to Week 6	6 weeks	The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.

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	Change in MADRS Total Score From Baseline to Week 6	6 weeks	modified Intent-to-Treat (mITT) Population	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in MADRS Total Score From Baseline to Week 6	AXS-05		15.91	Standard Error 0.921	score on a scale
Change in MADRS Total Score From Baseline to Week 6	Placebo		12.04	Standard Error 0.862	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AXS-05	163
Overall Study	STARTED	Placebo	164
Overall Study	COMPLETED	AXS-05	123
Overall Study	COMPLETED	Placebo	147
Overall Study	NOT COMPLETED	AXS-05	40
Overall Study	NOT COMPLETED	Placebo	17

Source ClinicalTrials.gov

Adverse events16

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	26	162	29
other	Dizziness	Nervous system disorders	Placebo	10	164	12
other	Nausea	Gastrointestinal disorders	AXS-05	21	162	24
other	Nausea	Gastrointestinal disorders	Placebo	14	164	14
other	Headache	Nervous system disorders	AXS-05	13	162	16
other	Headache	Nervous system disorders	Placebo	6	164	6
other	Diarrhea	Gastrointestinal disorders	AXS-05	11	162	11
other	Diarrhea	Gastrointestinal disorders	Placebo	5	164	5
other	Somnolence	Nervous system disorders	AXS-05	11	162	11
other	Somnolence	Nervous system disorders	Placebo	5	164	5

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AXS-05	0	162
Total, all-cause mortality	Placebo	0	164
Total, other adverse events	AXS-05	100	162
Total, other adverse events	Placebo	74	164
Total, serious adverse events	AXS-05	1	162
Total, serious adverse events	Placebo	0	164

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34510411	DERIVED	PubMed
35649167	DERIVED	PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
AXS-05 vs Placebo: deaths from any cause	Trial comparisons
AXS-05 vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04019704

GET https://conductscience.org/api/trials/v1/NCT04019704/registered

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