Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-03-07 @ 2:28 PM
Study NCT ID:
NCT05278104
Status:
COMPLETED
Last Update Posted:
2025-11-14
First Post:
2022-03-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test Different Ways to Measure the Effect of Atomoxetine on Impulsive Behavior in Young Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days.', 'description': 'Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)', 'eventGroups': [{'id': 'EG000', 'title': 'Atomoxetine', 'description': 'Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home. Day 9 to Day 14: Participants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 28, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (Matching Atomoxetine)', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 23, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Apathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) After Single Dose (at Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.'}, {'id': 'OG001', 'title': 'Placebo (Matching Atomoxetine)', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '0.8'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '1.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '1.7', 'estimateComment': 'The treatment effect was estimated regardless of concomitant/rescue medication use or nausea/vomiting (treatment policy). Treatment discontinuation was handled with a while-on-treatment strategy.', 'groupDescription': 'Change from baseline was analyzed with an ANCOVA model with the BIS-11 score at baseline as covariate and treatment as fixed factor.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'No formal hypothesis was tested.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.', 'description': 'The BIS-11 evaluates impulsiveness via 30 items scored on a 4-point scale (Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4). Total scores range from 30 (least impulsive) to 120 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness.\n\nThe data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving \\<90% of planned doses), their data were included in the analysis only up to the point of discontinuation.\n\nReported summary data was based on an ANCOVA with the BIS-11 score at baseline as a covariate and the treatment arm as fixed factor.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received one dose of the study drug (placebo or atomoxetine) on Day 1 and had study data available.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) at Steady State (at Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.'}, {'id': 'OG001', 'title': 'Placebo (Matching Atomoxetine)', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-4.1', 'upperLimit': '-0.5'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '1.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '0.3', 'estimateComment': 'The treatment effect was estimated regardless of concomitant/rescue medication use or nausea/vomiting (treatment policy). Treatment discontinuation was handled with a while-on-treatment strategy.', 'groupDescription': 'Change from baseline was analyzed with an ANCOVA model with the BIS-11 score at baseline as covariate and treatment as fixed factor.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'No formal hypothesis was tested.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Analysis based on the observation period: days 0 to 14, change from baseline calculated for Day 14.', 'description': 'The BIS-11 evaluates impulsiveness via 30 items scored on a 4-point scale (Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4). Total scores range from 30 (least impulsive) to 120 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness.\n\nThe data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving \\<90% of planned doses), their data were included in the analysis only up to the point of discontinuation.\n\nReported summary data was based on an ANCOVA with the BIS-11 score at baseline as a covariate and the treatment arm as fixed factor.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 90% (not more than one missed dose) of the planned doses of the study drug (placebo or atomoxetine) up to Day 14 and had study data available.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Total Score of Short Urgency, Perseverance, Premeditation, and Sensation Seeking-Positive Urgency Impulsive Behavior Scale (S-UPPS-P) Impulsive Behavior Scale After Single Dose (at Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.'}, {'id': 'OG001', 'title': 'Placebo (Matching Atomoxetine)', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '1.6'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '1.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '2.4', 'estimateComment': 'The treatment effect was estimated regardless of concomitant/rescue medication use or nausea/vomiting (treatment policy). Treatment discontinuation was handled with a while-on-treatment strategy.', 'groupDescription': 'Change from baseline was analyzed with an ANCOVA model with the S-UPPS-P score at baseline as covariate and treatment as fixed factor.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'No formal hypothesis was tested.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.', 'description': 'The S-UPPS-P assesses impulsivity across five traits using 20 items scored on a 4-point scale (Agree Strongly = 1; Agree Some = 2; Disagree Some = 3; Disagree Strongly = 4). Total scores range from 20 (least impulsive) to 80 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness.\n\nThe data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving \\<90% of planned doses), their data were included in the analysis only up to the point of discontinuation.\n\nReported summary data was based on an ANCOVA with the S-UPPS-P score at baseline as a covariate and the treatment arm as fixed factor.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received one dose of the study drug (placebo or atomoxetine) on Day 1 and had study data available.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Total Score of Short Urgency, Perseverance, Premeditation, and Sensation Seeking-Positive Urgency Impulsive Behavior Scale (S-UPPS-P) Impulsive Behavior Scale at Steady State (at Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.'}, {'id': 'OG001', 'title': 'Placebo (Matching Atomoxetine)', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '1.4'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '0.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '3.1', 'estimateComment': 'The treatment effect was estimated regardless of concomitant/rescue medication use or nausea/vomiting (treatment policy). Treatment discontinuation was handled with a while-on-treatment strategy.', 'groupDescription': 'Change from baseline was analyzed with an ANCOVA model with the S-UPPS-P score at baseline as covariate and treatment as fixed factor.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'No formal hypothesis was tested.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Analysis based on the observation period: days 0 to 14, change from baseline calculated for Day 14.', 'description': 'The S-UPPS-P assesses impulsivity across five traits using 20 items scored on a 4-point scale (Agree Strongly = 1; Agree Some = 2; Disagree Some = 3; Disagree Strongly = 4). Total scores range from 20 (least impulsive) to 80 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness.\n\nThe data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving \\<90% of planned doses), their data were included in the analysis only up to the point of discontinuation.\n\nReported summary data was based on an ANCOVA with the S-UPPS-P score at baseline as a covariate and the treatment arm as fixed factor.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 90% (not more than one missed dose) of the planned doses of the study drug (placebo or atomoxetine) up to Day 14 and had study data available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Treatment Emergent Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.'}, {'id': 'OG001', 'title': 'Placebo (Matching Atomoxetine)', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.'}], 'classes': [{'title': 'Treatment-emergent adverse events', 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000'}, {'value': '80.6', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-emergent serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days.', 'description': 'Treatment emergent adverse events are adverse events that occurred after treatment administration up to 4 days after the last dose of study drug.', 'unitOfMeasure': 'Percentage (%) of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were treated with at least one dose of study drug (i.e. placebo or atomoxetine).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atomoxetine', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.'}, {'id': 'FG001', 'title': 'Placebo (Matching Atomoxetine)', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Number of Patients Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Exclusion criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a multi-center, randomized, double-blind, placebo controlled parallel-group trial in participants with attention deficit hyperactivity disorder (ADHD). Eligible participants were randomized in a 1:1 ratio to receive either placebo or atomoxetine during a 2-week double-blind treatment period.', 'preAssignmentDetails': '63 male and female participants (32 atomoxetine, 31 placebo) were randomized and 62 participants were treated. Out of these, 58 completed the planned treatment and trial per protocol; 2 were erroneously randomized and discontinued (one treated and one not treated); 3 discontinued due to other reasons. All participants were free to withdraw at any time and were closely monitored.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atomoxetine', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.'}, {'id': 'BG001', 'title': 'Placebo (Matching Atomoxetine)', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '27.4', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '26.4', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who were treated with at least one dose of study drug (i.e. placebo or atomoxetine).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-28', 'size': 710200, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-23T04:47', 'hasProtocol': True}, {'date': '2024-02-05', 'size': 584419, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-23T04:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2022-03-11', 'resultsFirstSubmitDate': '2025-10-30', 'studyFirstSubmitQcDate': '2022-03-11', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-30', 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) After Single Dose (at Day 1)', 'timeFrame': 'Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.', 'description': 'The BIS-11 evaluates impulsiveness via 30 items scored on a 4-point scale (Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4). Total scores range from 30 (least impulsive) to 120 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness.\n\nThe data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving \\<90% of planned doses), their data were included in the analysis only up to the point of discontinuation.\n\nReported summary data was based on an ANCOVA with the BIS-11 score at baseline as a covariate and the treatment arm as fixed factor.'}, {'measure': 'Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) at Steady State (at Day 14)', 'timeFrame': 'Analysis based on the observation period: days 0 to 14, change from baseline calculated for Day 14.', 'description': 'The BIS-11 evaluates impulsiveness via 30 items scored on a 4-point scale (Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4). Total scores range from 30 (least impulsive) to 120 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness.\n\nThe data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving \\<90% of planned doses), their data were included in the analysis only up to the point of discontinuation.\n\nReported summary data was based on an ANCOVA with the BIS-11 score at baseline as a covariate and the treatment arm as fixed factor.'}, {'measure': 'Change From Baseline in Total Score of Short Urgency, Perseverance, Premeditation, and Sensation Seeking-Positive Urgency Impulsive Behavior Scale (S-UPPS-P) Impulsive Behavior Scale After Single Dose (at Day 1)', 'timeFrame': 'Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.', 'description': 'The S-UPPS-P assesses impulsivity across five traits using 20 items scored on a 4-point scale (Agree Strongly = 1; Agree Some = 2; Disagree Some = 3; Disagree Strongly = 4). Total scores range from 20 (least impulsive) to 80 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness.\n\nThe data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving \\<90% of planned doses), their data were included in the analysis only up to the point of discontinuation.\n\nReported summary data was based on an ANCOVA with the S-UPPS-P score at baseline as a covariate and the treatment arm as fixed factor.'}, {'measure': 'Change From Baseline in Total Score of Short Urgency, Perseverance, Premeditation, and Sensation Seeking-Positive Urgency Impulsive Behavior Scale (S-UPPS-P) Impulsive Behavior Scale at Steady State (at Day 14)', 'timeFrame': 'Analysis based on the observation period: days 0 to 14, change from baseline calculated for Day 14.', 'description': 'The S-UPPS-P assesses impulsivity across five traits using 20 items scored on a 4-point scale (Agree Strongly = 1; Agree Some = 2; Disagree Some = 3; Disagree Strongly = 4). Total scores range from 20 (least impulsive) to 80 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness.\n\nThe data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving \\<90% of planned doses), their data were included in the analysis only up to the point of discontinuation.\n\nReported summary data was based on an ANCOVA with the S-UPPS-P score at baseline as a covariate and the treatment arm as fixed factor.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Treatment Emergent Adverse Events and Serious Adverse Events', 'timeFrame': 'From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days.', 'description': 'Treatment emergent adverse events are adverse events that occurred after treatment administration up to 4 days after the last dose of study drug.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives are to investigate the effect of atomoxetine on impulsivity after single dose and at steady state measured by the total score of Barrett Impulsiveness Scale version 11 (BIS-11) and Short Urgency, Perseverance, Premeditation, and Sensation Seeking-Positive Urgency Impulsive Behavior Scale (S-UPPS-P) Impulsive Behavior Scale. The secondary objective is to evaluate the safety of atomoxetine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* Male and female subjects, 18-45 years of age at the time of consent meeting diagnostic criteria of Attention Deficit Hyperactivity Disorder (ADHD) per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) at screening visit and currently undergoing diagnostic assessment and/or treatment for ADHD\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.\n* A diagnosis of the moderate symptoms of ADHD confirmed with combined score of 4 or higher in Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) at Screening; Hyperactivity/Impulsivity subscale min 8 (at least moderate for impulsivity measure with ADHD checklist)\n* Able and willing to discontinue the use of any psychotropic medications for treatment of ADHD symptoms, as well as of all relevant co-medication for comorbid conditions during the study\n* Women of childbearing potential (WOCBP) \\[1\\] must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the patient information.\n\n 1. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation.\n\nExclusion criteria\n\n* Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder or major depressive disorder (MDD) with psychotic features at the time of screening.\n* Diagnosis of any mental disorder (according to DSM-5) that was primary focus of treatment within 6 months prior to Screening or at Baseline (as per clinical discretion of the investigator).\n\n --The following are not excluded: Substance Induced Mood Disorder, Major Depressive Disorder in remission, Generalized Anxiety Disorder in remission, Post-Traumatic Stress Disorder in remission, recreational/occasional substance use as long as willing to stop for duration of the study, Borderline Personality Disorder.\n* Any psychiatric disorder, including the ones mentioned under #1, that in the opinion of the investigator would compromise participants' safety and/or validity of the data.\n* Current or recent (in the 6 months prior to screening) suicidal ideation or behaviour of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS).\n* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), temperature, or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator.\n* Repeated measurement of systolic blood pressure outside the range of 90 to 145 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 45 to 95 beats per minute (bpm).\n* A marked baseline prolongation of QT/QTc interval (\\[QT/QTc = Time between start of the Q-wave and the end of the T-wave in an electrocardiogram / QT interval corrected for heart rate using the method of Fridericia (QTcF) or Bazett (QTcB)\\] such as QTc intervals that are repeatedly greater than 450 milliseconds (ms) in males or repeatedly greater than 470 ms in females) or any other relevant electrocardiogram (ECG) finding at screening.\n* A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome).\n* Further exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT05278104', 'briefTitle': 'A Study to Test Different Ways to Measure the Effect of Atomoxetine on Impulsive Behavior in Young Adults With Attention Deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Double-blind, Randomized, Parallel Group, Placebo Controlled Clinical Trial to Evaluate the Effects of Atomoxetine on Impulsivity in Behavioral Laboratory Tasks in Adult ADHD Patients', 'orgStudyIdInfo': {'id': '0352-2159'}, 'secondaryIdInfos': [{'id': '2021-005270-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atomoxetine', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.', 'interventionNames': ['Drug: Zentiva®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (matching Atomoxetine)', 'description': 'Day 1 and Day 8:\n\nAfter fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site.\n\nDay 2 to Day 7:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.\n\nDay 9 to Day 14:\n\nParticipants took a single dose of placebo (matching Atomoxetine) in the morning at home.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Zentiva®', 'type': 'DRUG', 'otherNames': ['Atomoxetin'], 'description': 'Zentiva®, oral, tablet', 'armGroupLabels': ['Atomoxetine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, oral, tablet', 'armGroupLabels': ['Placebo (matching Atomoxetine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen, AöR', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '55232', 'city': 'Alzey', 'country': 'Germany', 'facility': 'Rheinhessen-Fachklinik Alzey', 'geoPoint': {'lat': 49.74657, 'lon': 8.11513}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn AöR', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '60528', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}]}, '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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to:\n\nhttps://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}