Trial Outcomes & Findings for A Study in People With Depression to Test the Effects of BI 1358894 on Parts of the Brain That Are Involved in Emotions (NCT NCT03854578)

Last Updated: 2025-02-25

Results Overview

The primary endpoint was the mean BOLD signal % change in an emotional paradigm, based on the emotional faces from the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) in the corticolimbic system comprising the following eight brain regions of interest: * Amygdala left * Amygdala right * Dorsolateral prefrontal cortex left * Dorsolateral prefrontal cortex right * Insula left * Insula right * Anterior cingulate cortex left * Anterior cingulate cortex right

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

73 participants

Primary outcome timeframe

A 50 min scan, 6 hours following drug intake.

Results posted on

2025-02-25

Participant Flow

A single dose, randomized, placebo controlled Phase I study on the effects of BI 1358894 on functional magnetic resonance Imaging measurements in an emotional processing paradigm in patients with Major Depressive Disorder

All subjects were screened for eligibility to participate in trial. Subjects visited specialist site to ensure that they met all implemented inclusion/exclusion criteria, Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated

Participant milestones

Participant milestones
Measure	Placebo Matching to BI 1358894 Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 matching placebo the patient receive 1 film-coated tablet of Placebo.	Citalopram Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the first administration of BI 1358894 matching placebo the patient receive a oral administration of single dose of 20 milligram (mg) Citalopram (1 tablet of 20 mg).	BI 1358894 Oral administration of single dose of 100 milligram (mg) BI 1358894 (4 film-coated tablets of 25 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 the patient receive 1 film-coated tablet of Placebo.
Overall Study STARTED	24	24	25
Overall Study COMPLETED	24	24	25
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study in People With Depression to Test the Effects of BI 1358894 on Parts of the Brain That Are Involved in Emotions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Matching to BI 1358894 n=24 Participants Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 matching placebo the patient receive 1 film-coated tablet of Placebo.	Citalopram n=24 Participants Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the first administration of BI 1358894 matching placebo the patient receive a oral administration of single dose of 20 milligram (mg) Citalopram (1 tablet of 20 mg).	BI 1358894 n=25 Participants Oral administration of single dose of 100 milligram (mg) BI 1358894 (4 film-coated tablets of 25 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 the patient receive 1 film-coated tablet of Placebo.	Total n=73 Participants Total of all reporting groups
Age, Continuous	30.1 Years STANDARD_DEVIATION 5.6 • n=5 Participants	30.8 Years STANDARD_DEVIATION 6.5 • n=7 Participants	31.5 Years STANDARD_DEVIATION 6.8 • n=5 Participants	30.8 Years STANDARD_DEVIATION 6.3 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	48 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	24 Participants n=7 Participants	25 Participants n=5 Participants	71 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	21 Participants n=7 Participants	25 Participants n=5 Participants	69 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: A 50 min scan, 6 hours following drug intake.

Population: Evaluable set (ES): This patient set included all randomised patients who performed the functional Magnetic Resonance Imaging (fMRI) measurements and did not experience severe headaches directly before or during the fMRI measurements. In particular, patients who had to be replaced due to severe headaches were excluded from the ES.

Outcome measures

Outcome measures
Measure	Placebo Matching to BI 1358894 n=24 Participants Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 matching placebo the patient receive 1 film-coated tablet of Placebo.	Citalopram n=23 Participants Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the first administration of BI 1358894 matching placebo the patient receive a oral administration of single dose of 20 milligram (mg) Citalopram (1 tablet of 20 mg).	BI 1358894 n=22 Participants Oral administration of single dose of 100 milligram (mg) BI 1358894 (4 film-coated tablets of 25 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 the patient receive 1 film-coated tablet of Placebo.
Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) Amygdala left	0.305 Percent change Standard Deviation 0.119	0.290 Percent change Standard Deviation 0.134	0.223 Percent change Standard Deviation 0.093
Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) Amygdala right	0.364 Percent change Standard Deviation 0.136	0.291 Percent change Standard Deviation 0.146	0.282 Percent change Standard Deviation 0.071
Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) Dorsolateral prefrontal cortex left	0.065 Percent change Standard Deviation 0.146	0.044 Percent change Standard Deviation 0.111	0.049 Percent change Standard Deviation 0.109
Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) Dorsolateral prefrontal cortex right	0.131 Percent change Standard Deviation 0.202	0.117 Percent change Standard Deviation 0.183	0.125 Percent change Standard Deviation 0.105
Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) Insula left	0.162 Percent change Standard Deviation 0.146	0.110 Percent change Standard Deviation 0.107	0.075 Percent change Standard Deviation 0.126
Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) Insula right	0.157 Percent change Standard Deviation 0.133	0.137 Percent change Standard Deviation 0.107	0.1205 Percent change Standard Deviation 0.125
Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) Anterior cingulate cortex left	0.003 Percent change Standard Deviation 0.121	-0.027 Percent change Standard Deviation 0.074	-0.024 Percent change Standard Deviation 0.085
Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) Anterior cingulate cortex right	-0.008 Percent change Standard Deviation 0.131	-0.026 Percent change Standard Deviation 0.087	-0.018 Percent change Standard Deviation 0.101

SECONDARY outcome

Timeframe: A 50 min scan, 6 hours following drug intake.

Population: Evaluable set (ES): This patient set included all randomised patients who performed the fMRI measurements and did not experience severe headaches directly before or during the fMRI measurements. In particular, patients who had to be replaced due to severe headaches were excluded from the ES.

The secondary endpoint was the mean BOLD signal % change in an emotional paradigm (affective picture set - OASIS task) in the corticolimbic system, consisting of eight brain regions: * Amygdala left * Amygdala right * Dorsolateral prefrontal cortex left * Dorsolateral prefrontal cortex right * Insula left * Insula right * Anterior cingulate cortex left * Anterior cingulate cortex right

Outcome measures

Outcome measures
Measure	Placebo Matching to BI 1358894 n=24 Participants Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 matching placebo the patient receive 1 film-coated tablet of Placebo.	Citalopram n=23 Participants Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the first administration of BI 1358894 matching placebo the patient receive a oral administration of single dose of 20 milligram (mg) Citalopram (1 tablet of 20 mg).	BI 1358894 n=22 Participants Oral administration of single dose of 100 milligram (mg) BI 1358894 (4 film-coated tablets of 25 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 the patient receive 1 film-coated tablet of Placebo.
Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS). Amygdala left	0.231 Percent change Standard Deviation 0.123	0.185 Percent change Standard Deviation 0.130	0.148 Percent change Standard Deviation 0.100
Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS). Amygdala right	0.200 Percent change Standard Deviation 0.125	0.186 Percent change Standard Deviation 0.130	0.132 Percent change Standard Deviation 0.105
Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS). Dorsolateral prefrontal cortex left	0.269 Percent change Standard Deviation 0.132	0.262 Percent change Standard Deviation 0.178	0.147 Percent change Standard Deviation 0.141
Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS). Dorsolateral prefrontal cortex right	0.229 Percent change Standard Deviation 0.174	0.220 Percent change Standard Deviation 0.116	0.155 Percent change Standard Deviation 0.141
Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS). Insula left	0.279 Percent change Standard Deviation 0.132	0.270 Percent change Standard Deviation 0.125	0.164 Percent change Standard Deviation 0.114
Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS). Insula right	0.195 Percent change Standard Deviation 0.142	0.207 Percent change Standard Deviation 0.154	0.120 Percent change Standard Deviation 0.100
Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS). Anterior cingulate cortex left	0.089 Percent change Standard Deviation 0.100	0.071 Percent change Standard Deviation 0.081	0.027 Percent change Standard Deviation 0.110
Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS). Anterior cingulate cortex right	0.091 Percent change Standard Deviation 0.129	0.082 Percent change Standard Deviation 0.113	0.025 Percent change Standard Deviation 0.104

Adverse Events

Placebo Matching to BI 1358894

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Citalopram

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

BI 1358894

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

BI 1358894 +Citalopram

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Matching to BI 1358894 n=25 participants at risk Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 matching placebo the patient receive 1 film-coated tablet of Placebo.	Citalopram n=23 participants at risk Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the first administration of BI 1358894 matching placebo the patient receive a oral administration of single dose of 20 milligram (mg) Citalopram (1 tablet of 20 mg).	BI 1358894 n=23 participants at risk Oral administration of single dose of 100 milligram (mg) BI 1358894 (4 film-coated tablets of 25 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 the patient receive 1 film-coated tablet of Placebo.	BI 1358894 +Citalopram n=2 participants at risk This column is based on the treatment the patients actually did receive. Patient randomized to the Citalopram but received BI 1358894 instead of Placebo at the first planned time point. Citalopram blood concentrations of patient, randomised to BI 1358894, showed that the Patient has received but did not report Citalopram as co-medication, at an unknown dose.
Nervous system disorders Headache	40.0% 10/25 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	52.2% 12/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	73.9% 17/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	50.0% 1/2 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.
Nervous system disorders Dizziness	4.0% 1/25 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	4.3% 1/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	13.0% 3/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	0.00% 0/2 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.
Ear and labyrinth disorders Vertigo	4.0% 1/25 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	4.3% 1/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	0.00% 0/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	50.0% 1/2 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.
General disorders Fatigue	0.00% 0/25 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	17.4% 4/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	17.4% 4/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	0.00% 0/2 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.
Infections and infestations Nasopharyngitis	8.0% 2/25 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	0.00% 0/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	13.0% 3/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	0.00% 0/2 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.
Gastrointestinal disorders Nausea	12.0% 3/25 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	4.3% 1/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	4.3% 1/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	0.00% 0/2 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.
Gastrointestinal disorders Vomiting	4.0% 1/25 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	0.00% 0/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	8.7% 2/23 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.	0.00% 0/2 • From the time of administration of BI 1358894 or BI-matching placebo (in the placebo and Citalopram arm) until time of administration of BI 1358894 or BI-matching placebo + Residual effect period(14*24 h) or 0:00 AM on day after subject's trial termination date, whatever occurs earlier. Up to 14 days. Safety Set (SS): This subject set includes all randomised patients who received the study drugs (BI 1358894, Citalopram or placebo). Patient randomized to the BI 1358894 but received Placebo at both time points.

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.
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