Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-25 @ 3:47 AM
Study NCT ID:
NCT03638908
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2018-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kelly.chin@utsouthwestern.edu', 'phone': '2146456493', 'title': 'Kelly Chin, MD', 'organization': 'UTSouthwestern medical center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 months', 'eventGroups': [{'id': 'EG000', 'title': 'Fluoxetine', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily\n\nFluoxetine', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'excessive yawning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'acute bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'increased palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pulmonary Vascular Resistance (PVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change in PVR between baseline and follow-up will be utilized. PVR is calculated as \\[(Pulmonary Artery mean - wedge) / Fick Cardiac Output\\]. Fick CO will be used in computing PVR over thermodilution because Fick appears to have greater precision (but not accuracy). The calculation of PVR above is measured in woods unit. Change is derived by getting the difference between baseline and week 24 PVR (Week 24 minus Baseline). mean is then computed by getting the average of the change', 'unitOfMeasure': 'woods unit', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 out of the 8 subjects enrolled had complete- baseline and week 24- data for analysis'}, {'type': 'SECONDARY', 'title': '5-HIAA (HYDROXYINDOLE ACETIC ACID) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.375', 'spread': '0.182', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Urine for spot urine 5-HIAA will be collected at baseline and Week 24. Subjects will be on diet restriction 72 hours prior to urine collection. Sample will be the first morning urine on the visit day. Sample will be brought to site and then sent to affiliate outside laboratory for processing. 5HIAA results are expressed as a ratio to creatinine excretion in the unit "mg/g creatinine" Change 5-HIAA is derived by getting the difference between baseline and week 24 5HIAA results (Week 24 minus Baseline). mean is then computed by getting the average of the change', 'unitOfMeasure': 'mg/g CRT', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'unable to adequately analyze outcome as there were several missing data- values provided below are not meaningful.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Markers of Platelets and Endothelial Activation in PAH.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine- Baseline', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily'}], 'timeFrame': 'Baseline and Week 24', 'description': 'About 20ml blood will be obtained for plasma and serum at Baseline and Week 24. This will be placed in a red-top tube (serum, at least 1 ml) and blue-top tube. For the plasma tests, a plasma volume of 750 microL is required. Samples will be sent together, as a batch of 50 is required, on dry ice via overnight courier. Plasma will be obtained by drawing blood into a blue-top citrated tube, inverting the tube 6 times, and then centrifuging at 2000g for 10 minutes. The platelet poor plasma will be drawn off, and then re-centrifuged for 10 minutes before freezing.', 'reportingStatus': 'POSTED', 'populationDescription': 'unable to analyze outcome as this sub-study was dependent on obtaining additional funding- samples were collected but not processed to provide result'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exercise Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine- Baseline', 'description': 'subject data at baseline'}, {'id': 'OG001', 'title': 'Fluoxetine- Week 24', 'description': 'subject data at week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '380', 'spread': '80.7', 'groupId': 'OG000'}, {'value': '393', 'spread': '78.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24', 'description': 'Exercise capacity will be measure using the 6-minute walk test. Data collected at baseline and 24 were analyzed. The test will follow the ATS guidelines for 6MWT at all time.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 out of total enrolled had complete data for analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Functional Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily\n\nFluoxetine'}], 'timeFrame': 'baseline and 24', 'description': 'Functional class will be measured using the WHO functional class assessment. This is graded from WHO FC I to FC IV. Assessment will be completed by an investigator on the study at every visit.', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis was not done as study primary endpoint was not met- since primary endpoint was not met, no further analyses were completed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quick Inventory of Depressive Symptomatology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine- Baseline', 'description': 'subject data at baseline'}, {'id': 'OG001', 'title': 'Fluoxetine- Week 24', 'description': 'subject data at week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and Week 24.', 'description': 'Patient reported outcome will be assessed using the Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16) completed at baseline, week 12 and Week 24; baseline and week 24 reported. Each question is scored from minimum of 0 to a maximum of 3; total score ranges from 0 to 42. With zero being better outcome and 42 being severe outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 subjects of the total enrolled were included in the descriptive analysis. 1 subject did not complete the study'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Global Impression of Severity - Symptoms (PGIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily\n\nFluoxetine'}], 'timeFrame': 'baseline', 'description': 'PGIS questionnaire will be administered for global assessment of severity. This questionnaire is categorical and measures outcome from "none" being best outcome to "severe" being the worst outcome', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis was not done as study primary endpoint was not met- since primary endpoint was not met, no further analyses were completed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinician Global Impression of Severity - Symptoms (CGIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily\n\nFluoxetine'}], 'timeFrame': 'Week 12 and Week 24.', 'description': 'Global assessment of severity will be determined using Clinician global impression of severity - symptoms (CGIS). This questionnaire is categorical and measures outcome from "none" being best outcome to "severe" being the worst outcome', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis was not done as study primary endpoint was not met- since primary endpoint was not met, no further analyses were completed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Short Form 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily\n\nFluoxetine'}], 'timeFrame': 'baseline, Week 12 and Week 24.', 'description': 'Patient reported outcome will also be assessed using SF-36 completed at baseline, Week 12 and Week 24. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis was not done as study primary endpoint was not met- since primary endpoint was not met, no further analyses were completed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinician Global Impression of Change (CGI-change)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily\n\nFluoxetine'}], 'timeFrame': 'Weeks 12 and 24', 'description': 'CGI-change questionnaire will be completed for global assessment of severity. This questionnaire is categorical and measures outcome from "very much better" being best outcome to "very much worse" being the worst outcome', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis was not done as study primary endpoint was not met- since primary endpoint was not met, no further analyses were completed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluoxetine', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily\n\nFluoxetine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited solely from the clinic from November 2013 to November 2016', 'preAssignmentDetails': 'This was an open label study and all subjects were assigned to receive Fluoxetine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluoxetine', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily\n\nFluoxetine'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/ethnicity', 'categories': [{'title': 'White non-hispanic', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-01', 'size': 886245, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-25T14:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2018-07-12', 'resultsFirstSubmitDate': '2019-01-15', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-13', 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Markers of Platelets and Endothelial Activation in PAH.', 'timeFrame': 'Baseline and Week 24', 'description': 'About 20ml blood will be obtained for plasma and serum at Baseline and Week 24. This will be placed in a red-top tube (serum, at least 1 ml) and blue-top tube. For the plasma tests, a plasma volume of 750 microL is required. Samples will be sent together, as a batch of 50 is required, on dry ice via overnight courier. Plasma will be obtained by drawing blood into a blue-top citrated tube, inverting the tube 6 times, and then centrifuging at 2000g for 10 minutes. The platelet poor plasma will be drawn off, and then re-centrifuged for 10 minutes before freezing.'}, {'measure': 'Exercise Capacity', 'timeFrame': 'baseline and 24', 'description': 'Exercise capacity will be measure using the 6-minute walk test. Data collected at baseline and 24 were analyzed. The test will follow the ATS guidelines for 6MWT at all time.'}, {'measure': 'Functional Class', 'timeFrame': 'baseline and 24', 'description': 'Functional class will be measured using the WHO functional class assessment. This is graded from WHO FC I to FC IV. Assessment will be completed by an investigator on the study at every visit.'}, {'measure': 'Quick Inventory of Depressive Symptomatology', 'timeFrame': 'baseline and Week 24.', 'description': 'Patient reported outcome will be assessed using the Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16) completed at baseline, week 12 and Week 24; baseline and week 24 reported. Each question is scored from minimum of 0 to a maximum of 3; total score ranges from 0 to 42. With zero being better outcome and 42 being severe outcome'}, {'measure': 'Patient Global Impression of Severity - Symptoms (PGIS)', 'timeFrame': 'baseline', 'description': 'PGIS questionnaire will be administered for global assessment of severity. This questionnaire is categorical and measures outcome from "none" being best outcome to "severe" being the worst outcome'}, {'measure': 'Clinician Global Impression of Severity - Symptoms (CGIS)', 'timeFrame': 'Week 12 and Week 24.', 'description': 'Global assessment of severity will be determined using Clinician global impression of severity - symptoms (CGIS). This questionnaire is categorical and measures outcome from "none" being best outcome to "severe" being the worst outcome'}, {'measure': 'Short Form 36', 'timeFrame': 'baseline, Week 12 and Week 24.', 'description': 'Patient reported outcome will also be assessed using SF-36 completed at baseline, Week 12 and Week 24. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health'}, {'measure': 'Clinician Global Impression of Change (CGI-change)', 'timeFrame': 'Weeks 12 and 24', 'description': 'CGI-change questionnaire will be completed for global assessment of severity. This questionnaire is categorical and measures outcome from "very much better" being best outcome to "very much worse" being the worst outcome'}], 'primaryOutcomes': [{'measure': 'Pulmonary Vascular Resistance (PVR)', 'timeFrame': 'Baseline and Week 24', 'description': 'Change in PVR between baseline and follow-up will be utilized. PVR is calculated as \\[(Pulmonary Artery mean - wedge) / Fick Cardiac Output\\]. Fick CO will be used in computing PVR over thermodilution because Fick appears to have greater precision (but not accuracy). The calculation of PVR above is measured in woods unit. Change is derived by getting the difference between baseline and week 24 PVR (Week 24 minus Baseline). mean is then computed by getting the average of the change'}], 'secondaryOutcomes': [{'measure': '5-HIAA (HYDROXYINDOLE ACETIC ACID) Level', 'timeFrame': 'Baseline and Week 24', 'description': 'Urine for spot urine 5-HIAA will be collected at baseline and Week 24. Subjects will be on diet restriction 72 hours prior to urine collection. Sample will be the first morning urine on the visit day. Sample will be brought to site and then sent to affiliate outside laboratory for processing. 5HIAA results are expressed as a ratio to creatinine excretion in the unit "mg/g creatinine" Change 5-HIAA is derived by getting the difference between baseline and week 24 5HIAA results (Week 24 minus Baseline). mean is then computed by getting the average of the change'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'This protocol describes an open-label phase 2 clinical trial of fluoxetine in PAH looking at change in pulmonary vascular resistance (PVR) as the primary endpoint.\n\nIn this open-label clinical trial, 18 patients with pulmonary arterial hypertension will be given fluoxetine for 24 weeks. A Right Heart Catheterization will be performed at baseline and 24 weeks. Change in PVR will be the primary endpoint; other hemodynamic endpoints, quality of life, QIDS-SR depression scale, functional class and six-minute walk distance will also be evaluated.\n\nPrimary Hypothesis: Fluoxetine treatment for 24 weeks will lead to significantly lower pulmonary vascular resistance in 18 patients with PAH in patients treated in an open-label clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. WHO Group I PAH subtypes of idiopathic PAH and PAH associated with drugs / toxins, connective tissue disease, repaired congenital heart disease and unrepaired atrial septal defect\n2. Age 16-80\n3. WHO Functional Class II or III\n4. Right Heart Catheterization within 3 weeks of study entry with mPAP ≥ 25 mmHg, wedge ≤ 15 mmHg, and PVR ≥ 3 Wood units.\n5. Contraception use, (-) urine pregnancy test, not breast feeding (women of childbearing potential)\n6. One or more approved PAH therapies for ≥ 3 months, no change in dose for 1 month (endothelin-1 antagonist, phosphodiesterase-5 inhibitor, prostacyclin / prostacyclin analog). Novel approved therapies in one of the three existing classes will also be acceptable as background therapy if they become available during the course of the study; other medication classes are excluded\n\n Exclusion Criteria:\n7. WHO Functional Class IV or listed for lung transplant\n8. Moderate or greater obstructive lung disease: FEV1/FVC \\<70% and FEV1 \\<60%\n9. Moderate or greater restrictive lung disease: TLC or FVC \\<60% (if 50-60%: OK if TLC or FVC ≥50% + PFT stable x1 year + CT with no more than mild lung disease)\n10. Other cause for pulmonary hypertension: all other WHO group I diseases (including but not limited to liver disease, HIV), and WHO Groups II-V (i.e. left heart disease, lung disease, chronic PE and miscellaneous causes)24.\n\n 1. High probability VQ or positive CTA\n 2. Left ventricular ejection fraction \\<40%\n11. Depression\n12. Severe liver, renal or other medical or physical disease preventing completion of the study procedures\n13. Use of antidepressants within 3 months'}, 'identificationModule': {'nctId': 'NCT03638908', 'acronym': 'PAH', 'briefTitle': 'Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'A Phase 2, Open-label, Clinical Trial of Fluoxetine, a Selective Serotonin Reuptake Inhibitor, in the Treatment of Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'NIKK23'}, 'secondaryIdInfos': [{'id': 'STU 082013-045', 'type': 'OTHER', 'domain': 'UTSouthwestern Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fluoxetine', 'description': 'Dosing will be\n\n* Week 1-4: 20 mg daily\n* Week 5-8: 40 mg daily\n* Week 9-12: 60 mg daily\n* Week 13-24: 80 mg daily', 'interventionNames': ['Drug: Fluoxetine']}], 'interventions': [{'name': 'Fluoxetine', 'type': 'DRUG', 'armGroupLabels': ['Fluoxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Kelly Chin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}