Trial · NCT03595579

Assessing Symptomatic Clinical Episodes in Depression

NCT03595579, Phase 2, Completed, Axsome Therapeutics, Inc.; results first posted 2021-09-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Assessing Symptomatic Clinical Episodes in Depression. Trials, record NCT03595579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03595579

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Trial

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

Title: Assessing Symptomatic Clinical Episodes in Depression
NCT number: NCT03595579
Status: Completed
Phases: Phase 2
Enrollment: 97 participants, actual
Lead sponsor: Axsome Therapeutics, Inc.
Conditions: Major Depressive Disorder
Interventions: AXS-05, Bupropion
First posted: 2018-07-23
Last updated: 2021-09-24
Results first posted: 2021-09-24

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	MADRS Score - Overall Change From Baseline	Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)	The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. 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.
Other	MADRS Score - Change From Baseline to Week 6	6 weeks	The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. 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

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	MADRS Score - Overall Change From Baseline	Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)	modified Intent-to-Treat (mITT) Population	score on a scale	MEAN
OTHER_PRE_SPECIFIED	MADRS Score - Change From Baseline to Week 6	6 weeks	modified Intent-to-Treat (mITT) Population	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
MADRS Score - Overall Change From Baseline	AXS-05	13.7	Standard Error 0.63	score on a scale
MADRS Score - Overall Change From Baseline	Bupropion	8.8	Standard Error 0.68	score on a scale
MADRS Score - Change From Baseline to Week 6	AXS-05	17.2	Standard Error 1.4	score on a scale
MADRS Score - Change From Baseline to Week 6	Bupropion	12.1	Standard Error 1.5	score on a scale

Source ClinicalTrials.gov

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AXS-05	48
Overall Study	STARTED	Bupropion	49
Overall Study	mITT Population	AXS-05	43
Overall Study	mITT Population	Bupropion	37
Overall Study	Safety Population	AXS-05	48
Overall Study	Safety Population	Bupropion	48
Overall Study	COMPLETED	AXS-05	38
Overall Study	COMPLETED	Bupropion	35
Overall Study	NOT COMPLETED	AXS-05	10
Overall Study	NOT COMPLETED	Bupropion	14

Source ClinicalTrials.gov

Adverse events24

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
other	Constipation	Gastrointestinal disorders	AXS-05	3	48
other	Constipation	Gastrointestinal disorders	Bupropion	4	48
other	Diarrhea	Gastrointestinal disorders	AXS-05	3	48
other	Diarrhea	Gastrointestinal disorders	Bupropion	4	48
other	Dry mouth	Gastrointestinal disorders	AXS-05	5	48
other	Dry mouth	Gastrointestinal disorders	Bupropion	4	48
other	Nausea	Gastrointestinal disorders	AXS-05	8	48
other	Nausea	Gastrointestinal disorders	Bupropion	6	48
other	Decreased appetite	Metabolism and nutrition disorders	AXS-05	5	48
other	Decreased appetite	Metabolism and nutrition disorders	Bupropion	4	48

1 to 10 of 24Source ClinicalTrials.gov

See all 24 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	48
Total, all-cause mortality	Bupropion	0	48
Total, other adverse events	AXS-05	35	48
Total, other adverse events	Bupropion	30	48
Total, serious adverse events	AXS-05	0	48
Total, serious adverse events	Bupropion	0	48

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35582785	DERIVED

Source 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 Bupropion: deaths from any cause	Trial comparisons
AXS-05 vs Bupropion: 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/NCT03595579

GET https://conductscience.org/api/trials/v1/NCT03595579/events?page=2

API reference For AI assistants