Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT00136318
Status:
COMPLETED
Last Update Posted:
2013-03-21
First Post:
2005-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm.schaefer@kliniken-essen-mitte.de', 'phone': '+49201-17430001', 'title': 'Professor Dr. Martin Schaefer', 'organization': 'Kliniken Essen-Mitte, Department of Psychiatry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Random assignment of patients before the preobservation period followed by patient withdrawal from the trial independent of antidepressant treatment weakens the strength of the randomization.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Escitalopram', 'otherNumAtRisk': 90, 'otherNumAffected': 67, 'seriousNumAtRisk': 90, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo', 'otherNumAtRisk': 91, 'otherNumAffected': 78, 'seriousNumAtRisk': 91, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 55}], 'organSystem': 'General disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 23}], 'organSystem': 'General disorders'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 20}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'self-harming behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cerebral tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'severe depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Escitalopram', 'description': 'After the preobservation period, patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.\n\nPeginterferon alfa-2a :\n\nEscitalopram :\n\nRibavirin :'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.\n\nPeginterferon alfa-2a :\n\nPlacebo :\n\nRibavirin :'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '43'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '48', 'upperLimit': '69'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3', 'description': 'Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as "percentage of participants" with "MADRS scores \\> 13" (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analysis included only patients who received at least one of escitalopram or placebo. Between group differences for the primary outcome parameters were calculated with a chi-square test. For the primary end point (MADRS score of 13 or higher), we treated missing MADRS assessments by multiple imputation.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Escitalopram', 'description': 'After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.\n\nPeginterferon alfa-2a :\n\nEscitalopram :\n\nRibavirin :'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.\n\nPeginterferon alfa-2a :\n\nPlacebo :\n\nRibavirin :'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patients free of depression during 24 or 48 weeks of antiviral therapy', 'description': 'Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients per group who did not develop any depressive episode during 48 weeks of antiviral therapy.'}, {'type': 'SECONDARY', 'title': 'Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Escitalopram', 'description': 'After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.\n\nPeginterferon alfa-2a :\n\nEscitalopram :\n\nRibavirin :'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.\n\nPeginterferon alfa-2a :\n\nPlacebo :\n\nRibavirin :'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '15'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '28'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'major depression during 24 or 48 weeks of antiviral therapy', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.'}, {'type': 'SECONDARY', 'title': 'Severe Depression Defined as a MADRS Score of 25 or Higher', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Escitalopram', 'description': 'After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.\n\nPeginterferon alfa-2a :\n\nEscitalopram :\n\nRibavirin :'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.\n\nPeginterferon alfa-2a :\n\nPlacebo :\n\nRibavirin :'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '6'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'severe depression during 24 or 48 weeks of antiviral therapy', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36)', 'timeFrame': 'assessed 2,4,12,24 and 48 weeks of antiviral treatment', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained Virologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Escitalopram', 'description': 'After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.\n\nPeginterferon alfa-2a :\n\nEscitalopram :\n\nRibavirin :'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.\n\nPeginterferon alfa-2a :\n\nPlacebo :\n\nRibavirin :'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '66'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '57'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'assessed 24 weeks after end of antiviral treatment', 'description': '(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.'}, {'type': 'SECONDARY', 'title': 'Tolerability', 'timeFrame': 'assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Safety', 'timeFrame': 'assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Escitalopram', 'description': 'After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.\n\nPeginterferon alfa-2a :\n\nEscitalopram :\n\nRibavirin :'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.\n\nPeginterferon alfa-2a :\n\nPlacebo :\n\nRibavirin :'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Took first dose of study medication', 'groupId': 'FG000', 'numSubjects': '90'}, {'comment': 'Took first dose of study medication', 'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'reached end-point of antiviral treatment', 'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 208 of the 300 patients screened were enrolled between August 2004 and September 2008 in different centers in the pre-observation period. Overall 181 patients started the treatment period by taking escitalopram or placebo.', 'preAssignmentDetails': 'A total of 208 of the 300 patients screened were enrolled between August 2004 and September 2008. 92 patients did not meet the inclusion criteria, had exclusion criteria or did not want to participate in the trial.27 patients stopped the trial during the preobservation period before the trial started by taking antidepressant or placebo therapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Escitalopram', 'description': 'After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.\n\nPeginterferon alfa-2a :\n\nEscitalopram :\n\nRibavirin :'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.\n\nPeginterferon alfa-2a :\n\nPlacebo :\n\nRibavirin :'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.2', 'spread': '11', 'groupId': 'BG000'}, {'value': '48.5', 'spread': '11', 'groupId': 'BG001'}, {'value': '47.4', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-20', 'studyFirstSubmitDate': '2005-08-26', 'resultsFirstSubmitDate': '2012-10-25', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-20', 'studyFirstPostDateStruct': {'date': '2005-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher', 'timeFrame': '50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3', 'description': 'Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as "percentage of participants" with "MADRS scores \\> 13" (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)', 'timeFrame': 'Patients free of depression during 24 or 48 weeks of antiviral therapy', 'description': 'Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression'}, {'measure': 'Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria', 'timeFrame': 'major depression during 24 or 48 weeks of antiviral therapy'}, {'measure': 'Severe Depression Defined as a MADRS Score of 25 or Higher', 'timeFrame': 'severe depression during 24 or 48 weeks of antiviral therapy'}, {'measure': 'Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36)', 'timeFrame': 'assessed 2,4,12,24 and 48 weeks of antiviral treatment'}, {'measure': 'Sustained Virologic Response', 'timeFrame': 'assessed 24 weeks after end of antiviral treatment', 'description': '(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment)'}, {'measure': 'Tolerability', 'timeFrame': 'assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment'}, {'measure': 'Safety', 'timeFrame': 'assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pegasys-Induced depression'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '25359924', 'type': 'DERIVED', 'citation': 'Sarkar S, Sarkar R, Berg T, Schaefer M. Sadness and mild cognitive impairment as predictors for interferon-alpha-induced depression in patients with hepatitis C. Br J Psychiatry. 2015 Jan;206(1):45-51. doi: 10.1192/bjp.bp.113.141770. Epub 2014 Oct 30.'}, {'pmid': '22801672', 'type': 'DERIVED', 'citation': 'Schaefer M, Sarkar R, Knop V, Effenberger S, Friebe A, Heinze L, Spengler U, Schlaepfer T, Reimer J, Buggisch P, Ockenga J, Link R, Rentrop M, Weidenbach H, Fromm G, Lieb K, Baumert TF, Heinz A, Discher T, Neumann K, Zeuzem S, Berg T. Escitalopram for the prevention of peginterferon-alpha2a-associated depression in hepatitis C virus-infected patients without previous psychiatric disease: a randomized trial. Ann Intern Med. 2012 Jul 17;157(2):94-103. doi: 10.7326/0003-4819-157-2-201207170-00006.'}]}, 'descriptionModule': {'briefSummary': 'Primary end points\n\n* incidence of depression defined as a Montgomery Asberg Depression Scale Score (MADRS) of 13 or higher during antiviral therapy (up to 48 weeks, depending on genotype)\n* effect of an antidepressive pre-treatment over two weeks and a continuously concomitant treatment with Escitalopram (S-citalopram) on frequency and severity of depression in patients with chronic hepatitis C (HCV) treated with Peg-interferon alfa-2a (PEGASYS) and ribavirin, measured by the Montgomery Asberg Depression Scale\n\nSecondary end points\n\n* time to depression defined as a MADRS score of 13 or higher\n* incidence of major depression defined by Diagnostic and Statistical Manual IV (DSM-IV) criteria\n* severe depression according to MADRS scale (score 25 or higher)\n* Health related quality of life (HRQOL) measured by the Short Form 36 (SF-36)\n* sustained virologic response\n* tolerability\n* safety\n* changes/group differences in other psychiatric depression scales (Hamilton Depression Rating Scale, Beck Depression Inventory)\n\nOther investigations:\n\n* cognitive function, anxiety (word fluency test, trail making test part A and B, othe scales)\n* Predictive parameters for patients especially gaining from an antidepressive therapy (e.g. age, gender, weight, height, alanine aminotransferase (ALAT) quotient defined as median ALAT values before treatment divided by the upper standard value, HCV-RNA serum concentration level of fibrosis in liver histology, baseline values of the different psychometric scales)\n* alanine aminotransferase (ALAT), aspartate transaminase (ASAT), thyrotrophin (TSH)\n* biomarkers (genetic parameters, cytokines,...)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic hepatitis C infection defined as positive anti-HCV antibodies and serum HCV-RNA \\>1000 IU/ml, naive to antiviral treatment\n* age \\>18 years\n\nExclusion Criteria:\n\n* Antidepressive treatment within the last 3 years\n* Psychiatric diseases including major depressive disorders in past medical history\n* Active substance abuse during the last 12 months\n* Pregnancy, lactation, wish to become pregnant\n* Hepatitis B (HBV)/HIV-coinfection\n* Decompensated liver disease, hepatocellular carcinoma, history of bleeding esophageal varices\n* Neutropenia (\\<1500/ul), thrombocytopenia (\\<70/nl), anemia (\\<12g/dl in females, \\<13g/dl in males)\n* History of autoimmune disease\n* History of organ transplantation, concomitant liver disease, severe cardiopulmonary disease, hemolytic anemia, malignant disease'}, 'identificationModule': {'nctId': 'NCT00136318', 'acronym': 'CIPPAD', 'briefTitle': 'Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Efficacy and Tolerability of Escitalopram for the Prevention of Pegylated Interferon Alfa Associated Depression in Patients With Chronic Hepatitis C Infection: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'ML18075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Escitalopram', 'description': 'After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.', 'interventionNames': ['Drug: Escitalopram', 'Drug: Peginterferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.', 'interventionNames': ['Drug: Placebo', 'Drug: Peginterferon alfa-2a', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Escitalopram', 'type': 'DRUG', 'armGroupLabels': ['Escitalopram']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}, {'name': 'Peginterferon alfa-2a', 'type': 'DRUG', 'otherNames': ['PEG-IFN alfa-2a', 'Pegasys'], 'description': 'Patients with HCV genotype 1 or 4 received treatment for 48 weeks with PEGinterferon-alfa2a, 180 mcg weekly. Patients with genotype 2 or 3 received PEGinterferon-alfa2a, 180 mcg weekly.', 'armGroupLabels': ['Escitalopram', 'Placebo']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'Patients with HCV genotype 1 or 4 received treatment for 48 weeks with ribavirin, 1000 mg per day (body weight 75 kg) or 1200 mg per day (body weight, 75 kg). Patients with HCV genotype 2 or 3 received ribavirin, 800 mg per day for 24 weeks.', 'armGroupLabels': ['Escitalopram', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Department of Gastroenterolgy and Rheumatology, Sektion Hepatology', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Thomas Berg, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Charité'}, {'name': 'Martin Schaefer, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Martin Schaefer, MD', 'investigatorFullName': 'M. Schaefer, MD', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}