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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004763-12 | EudraCT Number |
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To assess the effect of a single dose of BI 1358894 compared to placebo on BOLD responses in modulating brain processing of emotional and cognitive stimuli on the amygdala and related brain structure using fMRI in in unmedicated patients with depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1358894 | Experimental |
| |
| Citalopram | Experimental |
| |
| Placebo matching BI 1358894 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1358894 | Drug | Film-coated tablet |
| |
| Placebo matching BI 1358894 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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:
| A 50 min scan, 6 hours following drug intake. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS). | 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36343427 | Derived | Grimm S, Keicher C, Paret C, Niedtfeld I, Beckmann C, Mennes M, Just S, Sharma V, Fuertig R, Herich L, Mack S, Thamer C, Schultheis C, Weigand A, Schmahl C, Wunder A. The effects of transient receptor potential cation channel inhibition by BI 1358894 on cortico-limbic brain reactivity to negative emotional stimuli in major depressive disorder. Eur Neuropsychopharmacol. 2022 Dec;65:44-51. doi: 10.1016/j.euroneuro.2022.10.009. Epub 2022 Nov 4. |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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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
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Randomised Set (RS): This patient set included all patients who were randomised to receive BI 1358894, Citalopram or placebo. Patients without any post-randomisation data were excluded from the primary and secondary pharmacodynamic analyses
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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:
| 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. | Posted | Mean | Standard Deviation | Percent change | A 50 min scan, 6 hours following drug intake. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2019 | Feb 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2019 | Feb 4, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000730434 | TRPC inhibitor BI 1358894 |
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Drug |
Film-coated tablet |
|
| Citalopram | Drug | Film-coated tablet |
|
| A 50 min scan, 6 hours following drug intake. |
| 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). |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | 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. |
| OG001 | 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). |
| OG002 | 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. |
|
|
|
| Secondary | Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS). | 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:
| 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. | Posted | Mean | Standard Deviation | Percent change | A 50 min scan, 6 hours following drug intake. |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 13 |
| 25 |
| EG001 | 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). | 0 | 23 | 0 | 23 | 13 | 23 |
| EG002 | 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. | 0 | 23 | 0 | 23 | 21 | 23 |
| EG003 | BI 1358894 +Citalopram | 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. | 0 | 2 | 0 | 2 | 2 | 2 |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
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.
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
|
| Dorsolateral prefrontal cortex left |
|
| Dorsolateral prefrontal cortex right |
|
| Insula left |
|
| Insula right |
|
| Anterior cingulate cortex left |
|
| Anterior cingulate cortex right |
|
| Mean BOLD signal % change/ Amygdala Right | ANOVA | 0.0480 | Mean change | -0.07 | Standard Error of the Mean | 0.03 | 2-Sided | 90 | -0.13 | -0.01 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Anterior Cingulate Cortex Left | ANOVA | 0.0294 | Mean change | -0.07 | Standard Error of the Mean | 0.03 | 2-Sided | 90 | -0.12 | -0.02 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Anterior Cingulate Cortex Right | ANOVA | 0.0359 | Mean change | -0.07 | Standard Error of the Mean | 0.03 | 2-Sided | 90 | -0.13 | -0.02 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left | ANOVA | 0.0022 | Mean change | -0.13 | Standard Error of the Mean | 0.04 | 2-Sided | 90 | -0.19 | -0.06 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right | ANOVA | 0.1040 | Mean change | -0.08 | Standard Error of the Mean | 0.05 | 2-Sided | 90 | -0.15 | 0.00 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Insula Left | ANOVA | 0.0022 | Mean change | -0.12 | Standard Error of the Mean | 0.04 | 2-Sided | 90 | -0.18 | -0.06 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Insula Right | ANOVA | 0.0331 | Mean change | -0.08 | Standard Error of the Mean | 0.04 | 2-Sided | 90 | -0.14 | -0.02 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Amygdala Left | ANOVA | 0.2149 | Mean change | -0.05 | Standard Error of the Mean | 0.04 | 2-Sided | 90 | -0.11 | 0.02 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Amygdala Right | ANOVA | 0.6896 | Mean change | -0.02 | Standard Error of the Mean | 0.04 | 2-Sided | 90 | -0.08 | 0.05 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Anterior Cingulate Cortex Left | ANOVA | 0.4769 | Mean change | -0.02 | Standard Error of the Mean | 0.03 | 2-Sided | 90 | -0.06 | 0.02 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Anterior Cingulate Cortex Right | ANOVA | 0.7680 | Mean change | -0.01 | Standard Error of the Mean | 0.03 | 2-Sided | 90 | -0.07 | 0.05 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left | ANOVA | 0.7997 | Mean change | -0.01 | Standard Error of the Mean | 0.04 | 2-Sided | 90 | -0.08 | 0.06 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right | ANOVA | 0.8334 | Mean change | -0.01 | Standard Error of the Mean | 0.04 | 2-Sided | 90 | -0.08 | 0.06 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Insula Left | ANOVA | 0.7402 | Mean change | -0.01 | Standard Error of the Mean | 0.04 | 2-Sided | 90 | -0.07 | 0.05 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |
| Mean BOLD signal % change/ Insula Right | ANOVA | 0.8120 | Mean change | 0.01 | Standard Error of the Mean | 0.04 | 2-Sided | 90 | -0.06 | 0.08 | Mean change calculated as: BI - Placebo. | Other | ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus <20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894. |