{"protocolSection":{"identificationModule":{"nctId":"NCT03854578","orgStudyIdInfo":{"id":"1402-0003"},"secondaryIdInfos":[{"id":"2017-004763-12","type":"EUDRACT_NUMBER"},{"id":"2017","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2017"}],"organization":{"fullName":"Boehringer Ingelheim","class":"INDUSTRY"},"briefTitle":"A Study in People With Depression to Test the Effects of BI 1358894 on Parts of the Brain That Are Involved in Emotions","officialTitle":"A Single Dose, Randomized, Placebo Controlled Phase I Study on the Effects of BI 1358894 on Functional MRI Measurements in an Emotional Processing Paradigm in Patients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2025-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-03-12","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-08-27","type":"ACTUAL"},"completionDateStruct":{"date":"2019-09-23","type":"ACTUAL"},"studyFirstSubmitDate":"2019-02-25","studyFirstSubmitQcDate":"2019-02-25","studyFirstPostDateStruct":{"date":"2019-02-26","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-02-06","resultsFirstSubmitQcDate":"2025-02-06","resultsFirstPostDateStruct":{"date":"2025-02-25","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-02-06","lastUpdatePostDateStruct":{"date":"2025-02-25","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Boehringer Ingelheim","class":"INDUSTRY"}},"oversightModule":{"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"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."},"conditionsModule":{"conditions":["Depressive Disorder, Major"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":73,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"BI 1358894","type":"EXPERIMENTAL","interventionNames":["Drug: BI 1358894"]},{"label":"Citalopram","type":"EXPERIMENTAL","interventionNames":["Drug: Citalopram"]},{"label":"Placebo matching BI 1358894","type":"EXPERIMENTAL","interventionNames":["Drug: Placebo matching BI 1358894"]}],"interventions":[{"type":"DRUG","name":"BI 1358894","description":"Film-coated tablet","armGroupLabels":["BI 1358894"]},{"type":"DRUG","name":"Placebo matching BI 1358894","description":"Film-coated tablet","armGroupLabels":["Placebo matching BI 1358894"]},{"type":"DRUG","name":"Citalopram","description":"Film-coated tablet","armGroupLabels":["Citalopram"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"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)","description":"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:\n\n* Amygdala left\n* Amygdala right\n* Dorsolateral prefrontal cortex left\n* Dorsolateral prefrontal cortex right\n* Insula left\n* Insula right\n* Anterior cingulate cortex left\n* Anterior cingulate cortex right","timeFrame":"A 50 min scan, 6 hours following drug intake."}],"secondaryOutcomes":[{"measure":"Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).","description":"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:\n\n* Amygdala left\n* Amygdala right\n* Dorsolateral prefrontal cortex left\n* Dorsolateral prefrontal cortex right\n* Insula left\n* Insula right\n* Anterior cingulate cortex left\n* Anterior cingulate cortex right","timeFrame":"A 50 min scan, 6 hours following drug intake."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients having a diagnosis of a MDD according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) (single episode or recurrent) with a MADRS total score between ≥ 7 and \\< 26 at screening.\n* Male or female aged 18 to 45 years, inclusive at screening.\n* Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control.\n* Patients must be, in the opinion of the Investigator, capable of and eligible for completing the fMRI and tasks.\n* Patients must be right-handed.\n* Patients must have acceptable weight as defined by BMI (weight \\[kg\\]/height \\[m\\]²) range of 18 to 30 kg/m², inclusive at Visit 1.\n* Patients must be a non-smoker or light smoker (≤ 5 cigarettes per day).\n* Patients must have signed the informed consent form prior to the first study-related procedure indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.\n* Further inclusion criteria apply\n\nExclusion Criteria:\n\n* Meeting any diagnostic criteria for a major psychiatric disorder (other than MDD), as determined by DSM-V at screening.\n* Has received a prescribed medication (including antidepressants) within 28 days prior to Visit 1 (apart from the contraceptive pill) or having received over the counter medication (including pain killers) within 10 days prior to screening. Participants who have taken prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.\n* Patients where it is foreseen (per investigator judgement) that a delay of initiation of standard of care therapy for the depressive disorder to 14 days after day 1 of Visit 2 is medically not justifiable.\n* A history of alcohol or substance dependence or abuse within the last 12 months from Visit 1.\n* Has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 4 or 5 for ideation on the C-SSRS, or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or treatment visit.\n* Has a history of, or presents (in the opinion of the Investigator) with, significant neurological or psychiatric conditions (such as stroke, traumatic brain injury, seizures, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, blackouts requiring hospitalisation).\n* A planned medical treatment within the study period that might interfere with the study procedures.\n* Further exclusion criteria apply","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"45 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Charité - Universitätsmedizin Berlin","city":"Berlin","zip":"10117","country":"Germany","geoPoint":{"lat":52.52437,"lon":13.41053}}]},"referencesModule":{"references":[{"pmid":"36343427","type":"DERIVED","citation":"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."}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"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:\n\n1. studies in products where Boehringer Ingelheim is not the license holder;\n2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;\n3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datasharing"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"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","recruitmentDetails":"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","groups":[{"id":"FG000","title":"Placebo Matching to BI 1358894","description":"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.\n\nThree hours after the administration of BI 1358894 matching placebo the patient receive 1 film-coated tablet of Placebo."},{"id":"FG001","title":"Citalopram","description":"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.\n\nThree 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)."},{"id":"FG002","title":"BI 1358894","description":"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.\n\nThree hours after the administration of BI 1358894 the patient receive 1 film-coated tablet of Placebo."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"24"},{"groupId":"FG002","numSubjects":"25"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"24"},{"groupId":"FG002","numSubjects":"25"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"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","groups":[{"id":"BG000","title":"Placebo Matching to BI 1358894","description":"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.\n\nThree hours after the administration of BI 1358894 matching placebo the patient receive 1 film-coated tablet of Placebo."},{"id":"BG001","title":"Citalopram","description":"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.\n\nThree 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)."},{"id":"BG002","title":"BI 1358894","description":"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.\n\nThree hours after the administration of BI 1358894 the patient receive 1 film-coated tablet of Placebo."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"73"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"30.1","spread":"5.6"},{"groupId":"BG001","value":"30.8","spread":"6.5"},{"groupId":"BG002","value":"31.5","spread":"6.8"},{"groupId":"BG003","value":"30.8","spread":"6.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"48"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"25"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"71"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"69"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"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)","description":"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:\n\n* Amygdala left\n* Amygdala right\n* Dorsolateral prefrontal cortex left\n* Dorsolateral prefrontal cortex right\n* Insula left\n* Insula right\n* Anterior cingulate cortex left\n* Anterior cingulate cortex right","populationDescription":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percent change","timeFrame":"A 50 min scan, 6 hours following drug intake.","groups":[{"id":"OG000","title":"Placebo Matching to BI 1358894","description":"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.\n\nThree hours after the administration of BI 1358894 matching placebo the patient receive 1 film-coated tablet of Placebo."},{"id":"OG001","title":"Citalopram","description":"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.\n\nThree 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)."},{"id":"OG002","title":"BI 1358894","description":"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.\n\nThree hours after the administration of BI 1358894 the patient receive 1 film-coated tablet of Placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"22"}]}],"classes":[{"title":"Amygdala left","categories":[{"measurements":[{"groupId":"OG000","value":"0.305","spread":"0.119"},{"groupId":"OG001","value":"0.290","spread":"0.134"},{"groupId":"OG002","value":"0.223","spread":"0.093"}]}]},{"title":"Amygdala right","categories":[{"measurements":[{"groupId":"OG000","value":"0.364","spread":"0.136"},{"groupId":"OG001","value":"0.291","spread":"0.146"},{"groupId":"OG002","value":"0.282","spread":"0.071"}]}]},{"title":"Dorsolateral prefrontal cortex left","categories":[{"measurements":[{"groupId":"OG000","value":"0.065","spread":"0.146"},{"groupId":"OG001","value":"0.044","spread":"0.111"},{"groupId":"OG002","value":"0.049","spread":"0.109"}]}]},{"title":"Dorsolateral prefrontal cortex right","categories":[{"measurements":[{"groupId":"OG000","value":"0.131","spread":"0.202"},{"groupId":"OG001","value":"0.117","spread":"0.183"},{"groupId":"OG002","value":"0.125","spread":"0.105"}]}]},{"title":"Insula left","categories":[{"measurements":[{"groupId":"OG000","value":"0.162","spread":"0.146"},{"groupId":"OG001","value":"0.110","spread":"0.107"},{"groupId":"OG002","value":"0.075","spread":"0.126"}]}]},{"title":"Insula right","categories":[{"measurements":[{"groupId":"OG000","value":"0.157","spread":"0.133"},{"groupId":"OG001","value":"0.137","spread":"0.107"},{"groupId":"OG002","value":"0.1205","spread":"0.125"}]}]},{"title":"Anterior cingulate cortex left","categories":[{"measurements":[{"groupId":"OG000","value":"0.003","spread":"0.121"},{"groupId":"OG001","value":"-0.027","spread":"0.074"},{"groupId":"OG002","value":"-0.024","spread":"0.085"}]}]},{"title":"Anterior cingulate cortex right","categories":[{"measurements":[{"groupId":"OG000","value":"-0.008","spread":"0.131"},{"groupId":"OG001","value":"-0.026","spread":"0.087"},{"groupId":"OG002","value":"-0.018","spread":"0.101"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Mean BOLD signal % change/ Amygdala Left","nonInferiorityType":"OTHER","nonInferiorityComment":"ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MontgomeryÅsberg Depression Rating Scale (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.","pValue":"0.0105","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.08","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.14","ciUpperLimit":"-0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.03","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG002"],"groupDescription":"Mean BOLD signal % change/ Amygdala Right","nonInferiorityType":"OTHER","nonInferiorityComment":"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.","pValue":"0.0134","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.08","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.14","ciUpperLimit":"-0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.03","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG002"],"groupDescription":"Mean BOLD signal % change/ Anterior Cingulate Cortex Left","nonInferiorityType":"OTHER","nonInferiorityComment":"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.","pValue":"0.3495","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.03","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.08","ciUpperLimit":"0.02","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.03","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG002"],"groupDescription":"Mean BOLD signal % change/ Anterior Cingulate Cortex right","nonInferiorityType":"OTHER","nonInferiorityComment":"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.","pValue":"0.7008","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.01","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.07","ciUpperLimit":"0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.03","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG002"],"groupDescription":"Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left","nonInferiorityType":"OTHER","nonInferiorityComment":"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.","pValue":"0.6635","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.02","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.08","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.04","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG002"],"groupDescription":"Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right","nonInferiorityType":"OTHER","nonInferiorityComment":"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.","pValue":"0.8792","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.01","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.09","ciUpperLimit":"0.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.05","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG002"],"groupDescription":"Mean BOLD signal % change/ Insula Left","nonInferiorityType":"OTHER","nonInferiorityComment":"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.","pValue":"0.0419","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.08","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.15","ciUpperLimit":"-0.02","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.04","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG002"],"groupDescription":"Mean BOLD signal % change/ Insula Right","nonInferiorityType":"OTHER","nonInferiorityComment":"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.","pValue":"0.1658","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.05","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.12","ciUpperLimit":"0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.04","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG001"],"groupDescription":"Mean BOLD Signal % change/ Amygdala Left","nonInferiorityType":"OTHER","nonInferiorityComment":"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.","pValue":"0.6673","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.02","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.08","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.04","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG001"],"groupDescription":"Mean BOLD Signal % Change/ Amygdala Right","nonInferiorityType":"OTHER","nonInferiorityComment":"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.","pValue":"0.0778","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.07","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.14","ciUpperLimit":"-0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.04","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG001"],"groupDescription":"Mean BOLD signal % change/ Anterior Cingulate Cortex Left","nonInferiorityType":"OTHER","nonInferiorityComment":"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.","pValue":"0.3258","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.03","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.08","ciUpperLimit":"0.02","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.03","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG001"],"groupDescription":"Mean BOLD signal % change/ Anterior Cingulate Cortex Right","nonInferiorityType":"OTHER","nonInferiorityComment":"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.","pValue":"0.5954","statisticalMethod":"ANOVA","paramType":"Mean change","paramValue":"-0.02","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.07","ciUpperLimit":"0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.03","estimateComment":"Mean change calculated as: BI - Placebo."},{"groupIds":["OG000","OG001"],"groupDescription":"Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left","nonInferiorityType":"OTHER","nonInferiorityComment":"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. 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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."},"pointOfContact":{"title":"Boehringer Ingelheim, Call Center","organization":"Boehringer Ingelheim","email":"clintriage.rdg@boehringer-ingelheim.com","phone":"1-800-243-0127"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2019-02-21","uploadDate":"2025-02-04T04:33","filename":"Prot_000.pdf","size":761311},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2019-10-22","uploadDate":"2025-02-04T04:33","filename":"SAP_001.pdf","size":300410}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"C000730434","term":"TRPC inhibitor BI 1358894"},{"id":"D015283","term":"Citalopram"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009570","term":"Nitriles"},{"id":"D001572","term":"Benzofurans"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}