Trial Outcomes & Findings for A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication (NCT NCT04937829)
NCT ID: NCT04937829
Last Updated: 2026-08-14
Results Overview
Maximum decrease from baseline (peak decrease) in Montgomery-Åsberg Depression Rating Scale (MADRS) score at any day within a 7-day interval. The MADRS evaluates ten core symptoms of depression. Nine of the items are based upon patient reports and one is on the rater's observation (apparent sadness) during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe). The possible total score is the sum of all items and could range from 0 to 60 (from normal with absence of symptoms to severe depression). Values presented are based on an analysis of covariance (ANCOVA) model, including treatment as discrete fixed effect and baseline MADRS total score as continuous fixed effect.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
59 participants
Primary outcome timeframe
Evaluations taken at baseline (day -63 to -3) and on day 1, 2, 4, 6 and 8 (with trial drug intake on day 1).
Results posted on
2026-08-14
Participant Flow
This was a single dosing, placebo-controlled, randomised, double-blinded (investigator and patient), parallel group trial in moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors \[SSRI\] or serotonin-norepinephrine reuptake inhibitors \[SNRI\]).
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects ) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Placebo
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took four placebo tablets matching in size and weight to BI 1569912 5 mg tablets, orally in the morning.
|
5 mg BI 1569912
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 5 milligram (mg) BI 1569912 (1 BI 1569912 5 mg tablet and 3 placebo tablets), orally in the morning.
|
20 mg BI 1569912
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 20 milligram (mg) BI 1569912 (4 BI 1569912 5 mg tablets), orally in the morning.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took four placebo tablets matching in size and weight to BI 1569912 5 mg tablets, orally in the morning.
|
5 mg BI 1569912
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 5 milligram (mg) BI 1569912 (1 BI 1569912 5 mg tablet and 3 placebo tablets), orally in the morning.
|
20 mg BI 1569912
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 20 milligram (mg) BI 1569912 (4 BI 1569912 5 mg tablets), orally in the morning.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took four placebo tablets matching in size and weight to BI 1569912 5 mg tablets, orally in the morning.
|
5 mg BI 1569912
n=20 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 5 milligram (mg) BI 1569912 (1 BI 1569912 5 mg tablet and 3 placebo tablets), orally in the morning.
|
20 mg BI 1569912
n=20 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 20 milligram (mg) BI 1569912 (4 BI 1569912 5 mg tablets), orally in the morning.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 12.3 • n=11 Participants
|
50.2 years
STANDARD_DEVIATION 14.0 • n=11 Participants
|
44.0 years
STANDARD_DEVIATION 15.3 • n=22 Participants
|
47.8 years
STANDARD_DEVIATION 14.0 • n=255 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=11 Participants
|
12 Participants
n=11 Participants
|
13 Participants
n=22 Participants
|
32 Participants
n=255 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=11 Participants
|
8 Participants
n=11 Participants
|
7 Participants
n=22 Participants
|
27 Participants
n=255 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=11 Participants
|
7 Participants
n=11 Participants
|
4 Participants
n=22 Participants
|
17 Participants
n=255 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=11 Participants
|
13 Participants
n=11 Participants
|
16 Participants
n=22 Participants
|
42 Participants
n=255 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=11 Participants
|
10 Participants
n=11 Participants
|
11 Participants
n=22 Participants
|
31 Participants
n=255 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=11 Participants
|
10 Participants
n=11 Participants
|
9 Participants
n=22 Participants
|
27 Participants
n=255 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Montgomery-Åsberg Depression Rating Scale (MADRS) score
|
36 Score on a scale
STANDARD_DEVIATION 5.4 • n=11 Participants
|
33.2 Score on a scale
STANDARD_DEVIATION 5.4 • n=11 Participants
|
34.8 Score on a scale
STANDARD_DEVIATION 6.5 • n=22 Participants
|
34.6 Score on a scale
STANDARD_DEVIATION 5.8 • n=255 Participants
|
PRIMARY outcome
Timeframe: Evaluations taken at baseline (day -63 to -3) and on day 1, 2, 4, 6 and 8 (with trial drug intake on day 1).Population: Full analysis set: patients who were randomised and treated with the study drug and who had a baseline MADRS measurement.
Maximum decrease from baseline (peak decrease) in Montgomery-Åsberg Depression Rating Scale (MADRS) score at any day within a 7-day interval. The MADRS evaluates ten core symptoms of depression. Nine of the items are based upon patient reports and one is on the rater's observation (apparent sadness) during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe). The possible total score is the sum of all items and could range from 0 to 60 (from normal with absence of symptoms to severe depression). Values presented are based on an analysis of covariance (ANCOVA) model, including treatment as discrete fixed effect and baseline MADRS total score as continuous fixed effect.
Outcome measures
| Measure |
Placebo
n=19 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took four placebo tablets matching in size and weight to BI 1569912 5 mg tablets, orally in the morning.
|
5 mg BI 1569912
n=20 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 5 milligram (mg) BI 1569912 (1 BI 1569912 5 mg tablet and 3 placebo tablets), orally in the morning.
|
20 mg BI 1569912
n=20 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 20 milligram (mg) BI 1569912 (4 BI 1569912 5 mg tablets), orally in the morning.
|
|---|---|---|---|
|
Maximum Decrease From Baseline (Peak Decrease) in Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Any Day Within a 7-day Interval
|
-19.3 Score on a scale
Standard Error na
Geometric standard error = 2.3
|
-16.8 Score on a scale
Standard Error na
Geometric standard error = 2.2
|
-19.9 Score on a scale
Standard Error na
Geometric standard error = 2.2
|
PRIMARY outcome
Timeframe: The on treatment period + Follow up period, up to 15 days.Population: Treated set: all patients who were randomised and treated with the study drug.
Number of patients with any drug-related Adverse Events.
Outcome measures
| Measure |
Placebo
n=19 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took four placebo tablets matching in size and weight to BI 1569912 5 mg tablets, orally in the morning.
|
5 mg BI 1569912
n=20 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 5 milligram (mg) BI 1569912 (1 BI 1569912 5 mg tablet and 3 placebo tablets), orally in the morning.
|
20 mg BI 1569912
n=20 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 20 milligram (mg) BI 1569912 (4 BI 1569912 5 mg tablets), orally in the morning.
|
|---|---|---|---|
|
Number of Patients With Drug-related Adverse Events
|
1 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Scale recorded at 7:00 hour (h) (Day 1), 22:30 h (Day 2), 70:30 h (Day 4), 118:30 h (Day 6), and 166:30 h (Day 8) post dose.Population: Full analysis set: patients who were randomised and treated with the study drug and who had a baseline MADRS measurement.
Montgomery-Åsberg Depression Rating Scale (MADRS) Area under the curve (AUC) 0-166:30, defined as the area under the response curve from pre-dose to the last measurement during inpatient stay at 166:30 h using the trapezoidal rule divided by full duration (166.5 h). The MADRS evaluates ten core symptoms of depression. Nine of the items are based upon patient reports and one is on the rater's observation (apparent sadness) during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe). The possible total score is the sum of all items and could range from 0 to 60 (from normal with absence of symptoms to severe depression). Values presented are based on an analysis of covariance (ANCOVA) model, including treatment as discrete fixed effect and baseline MADRS total score as continuous fixed effect.
Outcome measures
| Measure |
Placebo
n=19 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took four placebo tablets matching in size and weight to BI 1569912 5 mg tablets, orally in the morning.
|
5 mg BI 1569912
n=20 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 5 milligram (mg) BI 1569912 (1 BI 1569912 5 mg tablet and 3 placebo tablets), orally in the morning.
|
20 mg BI 1569912
n=20 Participants
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 20 milligram (mg) BI 1569912 (4 BI 1569912 5 mg tablets), orally in the morning.
|
|---|---|---|---|
|
Montgomery-Åsberg Depression Rating Scale (MADRS) Area Under the Curve (AUC) 0-166:30
|
3905.5 Scores on a scale * 8 days
Standard Error na
Geometric standard error = 342.7
|
3840.6 Scores on a scale * 8 days
Standard Error na
Geometric standard error = 334.7
|
3357.3 Scores on a scale * 8 days
Standard Error na
Geometric standard error = 331.1
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
5 mg BI 1569912
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
20 mg BI 1569912
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=19 participants at risk
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took four placebo tablets matching in size and weight to BI 1569912 5 mg tablets, orally in the morning.
|
5 mg BI 1569912
n=20 participants at risk
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 5 milligram (mg) BI 1569912 (1 BI 1569912 5 mg tablet and 3 placebo tablets), orally in the morning.
|
20 mg BI 1569912
n=20 participants at risk
Moderate-to-severe Major Depressive Disorder (MDD) patients on stable antidepressants (i.e. selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)) took a single dose of 20 milligram (mg) BI 1569912 (4 BI 1569912 5 mg tablets), orally in the morning.
|
|---|---|---|---|
|
General disorders and administration site conditions
Fatigue
|
5.3%
1/19 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
10.0%
2/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
5.3%
1/19 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/19 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
10.0%
2/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
5.0%
1/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
|
Nervous system disorders
Disturbance in attention
|
5.3%
1/19 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
5.0%
1/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
|
Nervous system disorders
Somnolence
|
5.3%
1/19 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
|
Psychiatric disorders
Irritability
|
5.3%
1/19 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
0.00%
0/20 • Adverse events: the on-treatment period: up to 8 days. All cause mortality: up to 15 days.
Treated set: all patients who were randomised and treated with the study drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER