Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT03390933
Status:
COMPLETED
Last Update Posted:
2024-10-17
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Identifying and Treating Depression in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'axs81@case.edu', 'phone': '216-778-8484', 'title': 'Dr. Ashwini Sehgal', 'organization': 'MetroHealth System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study sample size is small for multiple reasons, including more patients than anticipated scoring below the threshold on the PHQ-9 or already being on psychiatric medications before enrollment.\n\nconditions. There was no comparison group. As a result, we are unable to compare efficacy and safety with other treatments or to evaluate the potentially confounding effect of frequent interactions with the psychiatric nurse practitioner.'}}, 'adverseEventsModule': {'timeFrame': 'All side effects ASSESSED EVERY OTHER WEEK OVER A TWELVE WEEK PERIOD while patients were actively taking fluoxetine.', 'description': 'Participants will be seen on a weekly basis. Every other week, the study nurse practitioner will review any side effects the participant is having and record any adverse events. These check ins will be recorded on the study Progress Note and also the Fluoxetine Follow Up Checklist form. These notes will be reviewed on a weekly basis by the study team as a whole.', 'eventGroups': [{'id': 'EG000', 'title': 'Fluoxetine Group', 'description': 'Approximately 96 patients will be enrolled into the intervention (Phase II) over the duration of the entire study.\n\nFluoxetine: Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'notes': 'One individual had stomach pains/nausea after taking the 20 mg fluoxetine and withdrew from the project. This is a common side effect of fluoxetine.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Determine the Impact of Directly Observed Weekly Fluoxetine Treatment on Remission of Depression Among Hemodialysis Patients.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine Group', 'description': 'Approximately 96 patients will be enrolled into the intervention (Phase II) over the duration of the entire study.\n\nFluoxetine: Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'remission of depression, defined as a week 12 Patient Health Questionnaire 9 (PHQ-9) total score of \\<5. The survey consists of 9 questions to gauge depression/depressive symptoms. Each question asks - Over the last 2 weeks, how often have you been bothered by any of the following problems: Each questions 0-3 scale (0=not at all 1= several days 2= more than half the days 3=nearly every day ). Range =0min to 27max.\n\nA TOTAL SCORE OF ≥10 IS AN ESTABLISHED THRESHOLD FOR CLINICALLY RELEVANT DEPRESSIVE SYMPTOMS. Less than 5 is total remission of depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled 16\n\n* 13 Female\n* 13 African American\n* 1 Hispanic'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluoxetine Group', 'description': 'Approximately 96 patients will be enrolled into the intervention (Phase II) over the duration of the entire study.\n\nFluoxetine: Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Screened Via Chart Abstraction 1588 In person Screening Conducted 1248 Evaluated for Major Depression Disorder 110 Untreated for Major Depressive Disorder 27 Consented/enrolled into trial 16'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluoxetine Group', 'description': 'Approximately 96 patients will be enrolled into the intervention (Phase II) over the duration of the entire study.\n\nFluoxetine: Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PATIENT HEALTH QUESTIONNAIRE 9', 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '4.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '9 questions to gauge depression/depressive symptoms. Each question asks - Over the last 2 weeks, how often have you been bothered by any of the following problems: Each questions 0-3 scale (0=not at all 1= several days 2= more than half the days 3=nearly every day ). Range =0min to 27max.\n\nA TOTAL SCORE OF ≥10 IS AN ESTABLISHED THRESHOLD FOR CLINICALLY RELEVANT DEPRESSIVE SYMPTOMS.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-03', 'size': 366131, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-27T17:43', 'hasProtocol': True}, {'date': '2017-10-03', 'size': 87876, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-27T17:44', 'hasProtocol': False}, {'date': '2017-11-20', 'size': 167662, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-10T12:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The cross-sectional study will involve assessments of depressive symptoms (PHQ-9) and quality of life for 1083 patients. These data will be used to address Aim A. The single arm trial will involve 96 patients with DSM5-confirmed depression.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2017-10-12', 'resultsFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2017-12-28', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-15', 'studyFirstPostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Determine the Impact of Directly Observed Weekly Fluoxetine Treatment on Remission of Depression Among Hemodialysis Patients.', 'timeFrame': '3 years', 'description': 'remission of depression, defined as a week 12 Patient Health Questionnaire 9 (PHQ-9) total score of \\<5. The survey consists of 9 questions to gauge depression/depressive symptoms. Each question asks - Over the last 2 weeks, how often have you been bothered by any of the following problems: Each questions 0-3 scale (0=not at all 1= several days 2= more than half the days 3=nearly every day ). Range =0min to 27max.\n\nA TOTAL SCORE OF ≥10 IS AN ESTABLISHED THRESHOLD FOR CLINICALLY RELEVANT DEPRESSIVE SYMPTOMS. Less than 5 is total remission of depressive symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Hemodialysis-Induced Symptom']}, 'referencesModule': {'references': [{'pmid': '17942763', 'type': 'BACKGROUND', 'citation': 'Cohen SD, Norris L, Acquaviva K, Peterson RA, Kimmel PL. Screening, diagnosis, and treatment of depression in patients with end-stage renal disease. Clin J Am Soc Nephrol. 2007 Nov;2(6):1332-42. doi: 10.2215/CJN.03951106. Epub 2007 Oct 17.'}, {'pmid': '16598203', 'type': 'BACKGROUND', 'citation': 'Hedayati SS, Bosworth HB, Kuchibhatla M, Kimmel PL, Szczech LA. The predictive value of self-report scales compared with physician diagnosis of depression in hemodialysis patients. Kidney Int. 2006 May;69(9):1662-8. doi: 10.1038/sj.ki.5000308.'}, {'pmid': '16253733', 'type': 'BACKGROUND', 'citation': 'Watnick S, Wang PL, Demadura T, Ganzini L. Validation of 2 depression screening tools in dialysis patients. Am J Kidney Dis. 2005 Nov;46(5):919-24. doi: 10.1053/j.ajkd.2005.08.006.'}, {'pmid': '17369709', 'type': 'BACKGROUND', 'citation': 'Cohen SD, Kimmel PL. Nutritional status, psychological issues and survival in hemodialysis patients. Contrib Nephrol. 2007;155:1-17. doi: 10.1159/000100952.'}, {'pmid': '10792629', 'type': 'BACKGROUND', 'citation': 'Kimmel PL, Peterson RA, Weihs KL, Simmens SJ, Alleyne S, Cruz I, Veis JH. Multiple measurements of depression predict mortality in a longitudinal study of chronic hemodialysis outpatients. Kidney Int. 2000 May;57(5):2093-8. doi: 10.1046/j.1523-1755.2000.00059.x.'}, {'pmid': '7787151', 'type': 'BACKGROUND', 'citation': 'Kimmel PL, Peterson RA, Weihs KL, Simmens SJ, Boyle DH, Verme D, Umana WO, Veis JH, Alleyne S, Cruz I. Behavioral compliance with dialysis prescription in hemodialysis patients. J Am Soc Nephrol. 1995 Apr;5(10):1826-34. doi: 10.1681/ASN.V5101826.'}, {'pmid': '25278546', 'type': 'BACKGROUND', 'citation': 'Lacson E Jr, Bruce L, Li NC, Mooney A, Maddux FW. Depressive affect and hospitalization risk in incident hemodialysis patients. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1713-9. doi: 10.2215/CJN.01340214. Epub 2014 Oct 2.'}, {'pmid': '15496178', 'type': 'BACKGROUND', 'citation': 'Lopes AA, Albert JM, Young EW, Satayathum S, Pisoni RL, Andreucci VE, Mapes DL, Mason NA, Fukuhara S, Wikstrom B, Saito A, Port FK. Screening for depression in hemodialysis patients: associations with diagnosis, treatment, and outcomes in the DOPPS. Kidney Int. 2004 Nov;66(5):2047-53. doi: 10.1111/j.1523-1755.2004.00977.x.'}, {'pmid': '19423571', 'type': 'BACKGROUND', 'citation': 'Chiu YW, Teitelbaum I, Misra M, de Leon EM, Adzize T, Mehrotra R. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol. 2009 Jun;4(6):1089-96. doi: 10.2215/CJN.00290109. Epub 2009 May 7.'}, {'pmid': '35386606', 'type': 'DERIVED', 'citation': 'Kauffman KM, Dolata J, Figueroa M, Gunzler D, Huml A, Pencak J, Sajatovic M, Sehgal AR. Directly Observed Weekly Fluoxetine for Major Depressive Disorder Among Hemodialysis Patients: A Single-Arm Feasibility Trial. Kidney Med. 2022 Jan 17;4(3):100413. doi: 10.1016/j.xkme.2022.100413. eCollection 2022 Mar.'}]}, 'descriptionModule': {'briefSummary': "Depression is present in about 20-30% of hemodialysis patients and is associated with morbidity and mortality. However, depression is inadequately diagnosed and treated among dialysis patients. This is due in part to the overlap between depressive symptoms (e.g. appetite change, trouble sleeping, feeling tired) and symptoms related to persistent metabolic derangements in hemodialysis patients (e.g. nausea, nocturnal cramps, feeling washed out after treatment). The overlap between depressive symptoms and dialysis-related complications makes it difficult to diagnose and therefore to treat depression. In addition, prescription of antidepressant medication may increase an already high pill burden and result in poor adherence. Moreover, the evidence base to guide depression treatment among hemodialysis patients is limited. In the investigators' previous work, they developed methods to use latent variables and structural equation modeling to isolate depressive symptoms. Other investigators have demonstrated that directly observed treatment enhances the effectiveness of tuberculosis and HIV treatment.\n\nInvestigators now propose a cross-sectional study (Phase 1) followed by a single-arm clinical trial (Phase 2) at 17 dialysis facilities. The cross-sectional study will involve assessments of depressive symptoms (using the PHQ-9 screening instrument) as well as dialysis-related complications, anxiety, and quality of life (Quality of Life Questionnaire) in about 1083 patients. Investigators will then use structural equation modeling to develop and validate a hemodialysis-specific PHQ-9 (hdPHQ-9) that will isolate depressive symptoms. The trial will involve 96 patients with confirmed depression who will be assigned to directly observed weekly antidepressant treatment with fluoxetine. The primary outcome of the trial will be remission of depression at 12 weeks. The trial results will also be used to compare the responsiveness of the PHQ-9 and the hdPHQ-9. Investigators anticipate that the hdPHQ-9 will be a valid and responsive instrument that will isolate depressive symptoms in hemodialysis patients and ultimately improve the screening and diagnosis of depression. Investigators also expect that directly observed weekly fluoxetine treatment will be an effective way to manage depression among hemodialysis patients.", 'detailedDescription': "Depression is present in about 20-30% of hemodialysis patients and is associated with morbidity and mortality. However, depression is inadequately diagnosed and treated among dialysis patients. This is due in part to the overlap between depressive symptoms (e.g. appetite change, trouble sleeping, feeling tired) and symptoms related to persistent metabolic derangements in hemodialysis patients (e.g. nausea, nocturnal cramps, feeling washed out after treatment). The overlap between depressive symptoms and dialysis complications makes it difficult to diagnose and therefore to treat depression. In addition, prescription of antidepressant medication may increase an already high pill burden and result in poor adherence. Moreover, the evidence base to guide depression treatment among hemodialysis patients is limited. In the investigators' previous work, they developed methods to use latent variables and structural equation modeling to isolate depressive symptoms. Other investigators have demonstrated that directly observed treatment enhances the effectiveness of tuberculosis and HIV treatment.\n\nInvestigators now propose a cross-sectional study (Phase 1) followed by a single-arm clinical trial (Phase 2) at 17 dialysis facilities. The cross-sectional study will involve assessments of depressive symptoms (using the PHQ-9 screening instrument) as well as dialysis-related complications, anxiety, and quality of life (Quality of Life Questionnaire) in about 1083 patients. The investigators will then use structural equation modeling to develop and validate a hemodialysis-specific PHQ-9 (hdPHQ-9) that will isolate depressive symptoms. The trial will involve 96 patients with confirmed depression who will be assigned to directly observed weekly antidepressant treatment with fluoxetine. The primary outcome of the trial will be remission of depression at 12 weeks. The trial results will also be used to compare the responsiveness of the PHQ-9 and the hdPHQ-9.\n\nThe investigators anticipate that the hdPHQ-9 will be a valid and responsive instrument that will isolate depressive symptoms from dialysis complications and ultimately improve the screening and diagnosis of depression. They also expect that directly observed weekly fluoxetine treatment will be an effective way to manage depression among hemodialysis patients.\n\nInnovative features of the proposed project include the use of latent variables to address overlap, administration of a long acting weekly antidepressant, and directly observed treatment. The project has the potential not only to improve the diagnosis and management of depression among hemodialysis patients but also to improve their morbidity and mortality. Furthermore, it may serve as a model for future studies to isolate symptoms among overlapping medical conditions.\n\nAim A. To develop and validate a self-reported depression screening instrument that isolates depressive symptoms from hemodialysis-related complications.\n\nHypothesis: A hemodialysis-specific PHQ-9 (hdPHQ-9) will isolate depressive symptoms from dialysis complications.\n\nAim B. To determine the impact of directly observed weekly fluoxetine treatment on remission of depression among hemodialysis patients.\n\nHypothesis: About half of patients who have directly observed fluoxetine treatment will have remission of depression.\n\nAim C. To examine the responsiveness of the new depression screening instrument to depression treatment.\n\nHypothesis: Fluoxetine treatment will be associated with larger improvements in hdPHQ-9 scores than in PHQ-9 scores."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* currently on hemodialysis at a CDC dialysis unit\n* English speaking\n* able to provide informed consent\n\nExclusion Criteria:\n\n* on hemodialysis for less than 3 months\n* comorbid psychotic, bipolar, substance use dependence, Alzheimer's or dementia\n\nNot eligible for Phase II (intervention) if currently on antidepressant medication"}, 'identificationModule': {'nctId': 'NCT03390933', 'briefTitle': 'Identifying and Treating Depression in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'MetroHealth Medical Center'}, 'officialTitle': 'Using Latent Variables and Directly Observed Treatment to Improve the Diagnosis and Management of Depression Among Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'IRB17-00768'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluoxetine Group', 'description': 'Approximately 96 patients will be enrolled into the intervention (Phase II) over the duration of the entire study.', 'interventionNames': ['Drug: Fluoxetine']}], 'interventions': [{'name': 'Fluoxetine', 'type': 'DRUG', 'otherNames': ['Prozac'], 'description': 'Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist.', 'armGroupLabels': ['Fluoxetine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Ash Seghal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MetroHealth Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MetroHealth Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ash Sehgal', 'investigatorAffiliation': 'MetroHealth Medical Center'}}}}