Trial Outcomes & Findings for A Biomarker-Guided, Randomized, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With TRD (NCT NCT05113771)
NCT ID: NCT05113771
Last Updated: 2025-05-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
197 participants
Primary outcome timeframe
Baseline to Day 42
Results posted on
2025-05-15
Participant Flow
Intent to treat (ITT) population 196 (65 participants in Liafensine 1mg arm, 64 patients in Liafensine 2mg arm, and 67 patients in placebo arm). Total 197 patients were initially randomized, but one patient was not dosed.
Participant milestones
| Measure |
Liafensine 1mg
Patients with TRD were treated with liafensine 1 mg QD for 6 weeks.
Liafensine: Liafensine
|
Liafensine 2mg
Patients with TRD were treated with liafensine 2 mg QD for 6 weeks.
Liafensine: Liafensine
|
Placebo
Patients with TRD were treated with placebo 1 mg QD for 6 weeks.
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
67
|
|
Overall Study
Intent To Treat (ITT): All Patients Who Took at Least One Dose
|
65
|
64
|
67
|
|
Overall Study
DGM4Positive Analysis Set: Patients Who Took at Least 1 Dose Study Drug & Had an Efficacy Evaluation
|
62
|
61
|
63
|
|
Overall Study
COMPLETED
|
61
|
49
|
52
|
|
Overall Study
NOT COMPLETED
|
4
|
16
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
Baseline characteristics by cohort
| Measure |
Liafensine 1mg
n=65 Participants
Patients with TRD were treated with liafensine 1 mg QD for 6 weeks.
Liafensine: Liafensine
|
Liafensine 2mg
n=64 Participants
Patients with TRD were treated with liafensine 2 mg QD for 6 weeks.
Liafensine: Liafensine
|
Placebo
n=67 Participants
Patients with TRD were treated with placebo 1 mg QD for 6 weeks.
Placebo: Placebo
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
0 Participants
n=7 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
0 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
0 Participants
n=4 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
60 Participants
n=7 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
62 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
177 Participants
n=4 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
4 Participants
n=7 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
5 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
19 Participants
n=4 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 15.47 • n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
42.2 years
STANDARD_DEVIATION 13.96 • n=7 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
43.9 years
STANDARD_DEVIATION 14.81 • n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
43.2 years
STANDARD_DEVIATION 14.71 • n=4 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
45 Participants
n=7 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
36 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
122 Participants
n=4 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
19 Participants
n=7 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
31 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
74 Participants
n=4 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
|
Race/Ethnicity, Customized
Asian
|
33 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
32 Participants
n=7 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
32 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
97 Participants
n=4 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
0 Participants
n=7 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
2 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
3 Participants
n=4 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
|
Race/Ethnicity, Customized
white
|
31 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
32 Participants
n=7 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
32 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
95 Participants
n=4 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
|
Race/Ethnicity, Customized
other
|
0 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
0 Participants
n=7 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
1 Participants
n=5 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
1 Participants
n=4 Participants • Intent to treat (ITT) population is equal to196 (65 participants in liafensine 1mg arm, 64 patients in liafensine 2mg arm, and 67 patients in placebo arm), which is including all patients who took at least 1 dose of study drug. Total of 197 patients were initially randomized and one randomized patient was not dosed.
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
33 participants
n=7 Participants
|
32 participants
n=5 Participants
|
95 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
China
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
32 participants
n=5 Participants
|
95 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 42The 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.
Outcome measures
| Measure |
Liafensine 1mg
n=62 Participants
Patients with TRD were treated with liafensine 1 mg QD for 6 weeks.
Liafensine: Liafensine
|
Liafensine 2mg
n=61 Participants
Patients with TRD were treated with liafensine 2 mg QD for 6 weeks.
Liafensine: Liafensine
|
Liafensine 1mg or 2 mg
n=123 Participants
Patients with TRD were treated with liafensine 1 mg or 2mg QD for 6 weeks.
Treatment: Liafensine
|
Placebo
n=63 Participants
Patients with TRD were treated with placebo 1 mg QD for 6 weeks.
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 42, in DGM4-positive Patients
|
-15.4 Units on a Scale
Standard Error 1.25
|
-15.5 Units on a Scale
Standard Error 1.30
|
-15.4 Units on a Scale
Standard Error 0.90
|
-11.0 Units on a Scale
Standard Error 1.31
|
SECONDARY outcome
Timeframe: Baseline to Day 42The 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.
Outcome measures
| Measure |
Liafensine 1mg
n=62 Participants
Patients with TRD were treated with liafensine 1 mg QD for 6 weeks.
Liafensine: Liafensine
|
Liafensine 2mg
n=61 Participants
Patients with TRD were treated with liafensine 2 mg QD for 6 weeks.
Liafensine: Liafensine
|
Liafensine 1mg or 2 mg
n=123 Participants
Patients with TRD were treated with liafensine 1 mg or 2mg QD for 6 weeks.
Treatment: Liafensine
|
Placebo
n=63 Participants
Patients with TRD were treated with placebo 1 mg QD for 6 weeks.
Placebo: Placebo
|
|---|---|---|---|---|
|
Change From Baseline to Day 42 in Clinical Global Impression-Severity Scale (CGI-S) Score in DGM4 Positive Patients
|
-1.5 Units on a scale
Standard Error 0.15
|
-1.5 Units on a scale
Standard Error 0.16
|
-1.5 Units on a scale
Standard Error 0.11
|
-1.1 Units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: 42 daysTo 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
Outcome measures
| Measure |
Liafensine 1mg
n=62 Participants
Patients with TRD were treated with liafensine 1 mg QD for 6 weeks.
Liafensine: Liafensine
|
Liafensine 2mg
n=61 Participants
Patients with TRD were treated with liafensine 2 mg QD for 6 weeks.
Liafensine: Liafensine
|
Liafensine 1mg or 2 mg
n=123 Participants
Patients with TRD were treated with liafensine 1 mg or 2mg QD for 6 weeks.
Treatment: Liafensine
|
Placebo
n=63 Participants
Patients with TRD were treated with placebo 1 mg QD for 6 weeks.
Placebo: Placebo
|
|---|---|---|---|---|
|
The Clinical Global Impression-Improvement Scale (CGI-I) (Range = 1-7, With Higher Score Indicating Worsening) Was Assessed in DGM4 Positive Patients
|
2.3 units on a scale
Standard Deviation 0.88
|
2.4 units on a scale
Standard Deviation 1.08
|
2.3 units on a scale
Standard Deviation 0.97
|
2.9 units on a scale
Standard Deviation 1.28
|
Adverse Events
Liafensine 1mg
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Liafensine 2mg
Serious events: 3 serious events
Other events: 37 other events
Deaths: 1 deaths
Placebo
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liafensine 1mg
n=65 participants at risk
Patients with TRD were treated with liafensine 1 mg QD for 6 weeks.
Liafensine: Liafensine
|
Liafensine 2mg
n=64 participants at risk
Patients with TRD were treated with liafensine 2 mg QD for 6 weeks.
Liafensine: Liafensine
|
Placebo
n=67 participants at risk
Patients with TRD were treated with placebo 1 mg QD for 6 weeks.
Placebo: Placebo
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.6%
1/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
0.00%
0/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.6%
1/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
0.00%
0/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.6%
1/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
0.00%
0/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.6%
1/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
0.00%
0/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Vascular disorders
Intestinal Haematoma
|
0.00%
0/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.6%
1/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
0.00%
0/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Psychiatric disorders
Depression
|
0.00%
0/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
0.00%
0/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
3.0%
2/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
General disorders
Death
|
0.00%
0/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.6%
1/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
0.00%
0/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
Other adverse events
| Measure |
Liafensine 1mg
n=65 participants at risk
Patients with TRD were treated with liafensine 1 mg QD for 6 weeks.
Liafensine: Liafensine
|
Liafensine 2mg
n=64 participants at risk
Patients with TRD were treated with liafensine 2 mg QD for 6 weeks.
Liafensine: Liafensine
|
Placebo
n=67 participants at risk
Patients with TRD were treated with placebo 1 mg QD for 6 weeks.
Placebo: Placebo
|
|---|---|---|---|
|
Nervous system disorders
Headach
|
30.8%
20/65 • Number of events 65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
21.9%
14/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
22.4%
15/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Nervous system disorders
Somnolence
|
7.7%
5/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
9.4%
6/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.5%
1/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Nervous system disorders
Dizziness
|
12.3%
8/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
3.1%
2/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
7.5%
5/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Gastrointestinal disorders
Nausea
|
16.9%
11/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
7.8%
5/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
10.4%
7/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Gastrointestinal disorders
Constipation
|
10.8%
7/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
9.4%
6/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
0.00%
0/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
5/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
0.00%
0/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
0.00%
0/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
4/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.6%
1/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.5%
1/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Psychiatric disorders
Anxiety
|
7.7%
5/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
0.00%
0/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
3.0%
2/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Psychiatric disorders
Depression
|
0.00%
0/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.6%
1/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
7.5%
5/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
7.8%
5/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
4.5%
3/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Infections and infestations
Influenza
|
6.2%
4/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.6%
1/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.5%
1/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
General disorders
Fatigue
|
6.2%
4/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.6%
1/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
1.5%
1/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
4/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
9.4%
6/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
3.0%
2/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
5/65 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
4.7%
3/64 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
7.5%
5/67 • 42 days
Treatment Emergent Adverse Events (TEAEs) (Safety Analysis Set) was performed. One randomized patient was not dosed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place