Trial · NCT05113771

A Biomarker-Guided, Randomized, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With TRD

NCT05113771, Phase 2, Completed, Denovo Biopharma LLC; results first posted 2025-05-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Biomarker-Guided, Randomized, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With TRD. Trials, record NCT05113771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05113771

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Trial

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

Title: A Biomarker-Guided, Randomized, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With TRD
NCT number: NCT05113771
Status: Completed
Phases: Phase 2
Enrollment: 197 participants, actual
Lead sponsor: Denovo Biopharma LLC
Conditions: Treatment Resistant Depression
Interventions: Liafensine, Placebo
First posted: 2021-11-09
Last updated: 2025-05-15
Results first posted: 2025-05-15

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Change in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 42, in DGM4-positive Patients	Baseline to Day 42	The primary objective of this study was change of Montgomery Åsberg Depression Rating Scale (MADRS) total score (range = 0 60, with higher scores indicating more severe depression) in DGM4 positive patients who were treated with liafensine versus placebo.
Secondary	Change From Baseline to Day 42 in Clinical Global Impression-Severity Scale (CGI-S) Score in DGM4 Positive Patients	Baseline to Day 42	The secondary endpoint was the change from baseline to Day 42 in Clinical Global Impression-Severity Scale CGI-S score (range = 1-7, with higher scores indicating greater illness) in DGM4 positive patients.
Secondary	The Clinical Global Impression-Improvement Scale (CGI-I) (Range = 1-7, With Higher Score Indicating Worsening) Was Assessed in DGM4 Positive Patients	42 days	To evaluate the Clinical Global Impression-Improvement Scale (CGI I) (range = 1-7, with higher score indicating worsening) at Day 42 in DGM4 positive patients with TRD treated with liafensine vs placebo

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 42, in DGM4-positive Patients	Baseline to Day 42	Units on a Scale	MEAN
SECONDARY	Change From Baseline to Day 42 in Clinical Global Impression-Severity Scale (CGI-S) Score in DGM4 Positive Patients	Baseline to Day 42	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	The Clinical Global Impression-Improvement Scale (CGI-I) (Range = 1-7, With Higher Score Indicating Worsening) Was Assessed in DGM4 Positive Patients	42 days	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Change in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 42, in DGM4-positive Patients	Liafensine 1mg	-15.4	Standard Error 1.25	Units on a Scale
Change in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 42, in DGM4-positive Patients	Liafensine 2mg	-15.5	Standard Error 1.30	Units on a Scale
Change in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 42, in DGM4-positive Patients	Liafensine 1mg or 2 mg	-15.4	Standard Error 0.90	Units on a Scale
Change in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 42, in DGM4-positive Patients	Placebo	-11.0	Standard Error 1.31	Units on a Scale
Change From Baseline to Day 42 in Clinical Global Impression-Severity Scale (CGI-S) Score in DGM4 Positive Patients	Liafensine 1mg	-1.5	Standard Error 0.15	Units on a scale
Change From Baseline to Day 42 in Clinical Global Impression-Severity Scale (CGI-S) Score in DGM4 Positive Patients	Liafensine 2mg	-1.5	Standard Error 0.16	Units on a scale
Change From Baseline to Day 42 in Clinical Global Impression-Severity Scale (CGI-S) Score in DGM4 Positive Patients	Liafensine 1mg or 2mg	-1.5	Standard Error 0.11	Units on a scale
Change From Baseline to Day 42 in Clinical Global Impression-Severity Scale (CGI-S) Score in DGM4 Positive Patients	Placebo	-1.1	Standard Error 0.15	Units on a scale
The Clinical Global Impression-Improvement Scale (CGI-I) (Range = 1-7, With Higher Score Indicating Worsening) Was Assessed in DGM4 Positive Patients	Liafensine 1mg	2.3	Standard Deviation 0.88	units on a scale
The Clinical Global Impression-Improvement Scale (CGI-I) (Range = 1-7, With Higher Score Indicating Worsening) Was Assessed in DGM4 Positive Patients	Liafensine 2mg	2.4	Standard Deviation 1.08	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Liafensine 1mg	65
Overall Study	STARTED	Liafensine 2mg	65
Overall Study	STARTED	Placebo	67
Overall Study	Intent To Treat (ITT): All Patients Who Took at Least One Dose	Liafensine 1mg	65
Overall Study	Intent To Treat (ITT): All Patients Who Took at Least One Dose	Liafensine 2mg	64
Overall Study	Intent To Treat (ITT): All Patients Who Took at Least One Dose	Placebo	67
Overall Study	DGM4Positive Analysis Set: Patients Who Took at Least 1 Dose Study Drug & Had an Efficacy Evaluation	Liafensine 1mg	62
Overall Study	DGM4Positive Analysis Set: Patients Who Took at Least 1 Dose Study Drug & Had an Efficacy Evaluation	Liafensine 2mg	61
Overall Study	DGM4Positive Analysis Set: Patients Who Took at Least 1 Dose Study Drug & Had an Efficacy Evaluation	Placebo	63
Overall Study	COMPLETED	Liafensine 1mg	61

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events63

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	Headach	Nervous system disorders	Liafensine 1mg	20	65	65
other	Headach	Nervous system disorders	Liafensine 2mg	14	64
other	Headach	Nervous system disorders	Placebo	15	67
other	Somnolence	Nervous system disorders	Liafensine 1mg	5	65
other	Somnolence	Nervous system disorders	Liafensine 2mg	6	64
other	Somnolence	Nervous system disorders	Placebo	1	67
other	Dizziness	Nervous system disorders	Liafensine 1mg	8	65
other	Dizziness	Nervous system disorders	Liafensine 2mg	2	64
other	Dizziness	Nervous system disorders	Placebo	5	67
other	Nausea	Gastrointestinal disorders	Liafensine 1mg	11	65

1 to 10 of 63Source ClinicalTrials.gov

See all 63 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Liafensine 1mg	0	65
Total, all-cause mortality	Liafensine 2mg	1	64
Total, all-cause mortality	Placebo	0	67
Total, other adverse events	Liafensine 1mg	36	65
Total, other adverse events	Liafensine 2mg	37	64
Total, other adverse events	Placebo	38	67
Total, serious adverse events	Liafensine 1mg	0	65
Total, serious adverse events	Liafensine 2mg	3	64
Total, serious adverse events	Placebo	2	67

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40928787	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 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.

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/NCT05113771

GET https://conductscience.org/api/trials/v1/NCT05113771/events?page=2

API reference For AI assistants