Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT00398632
Status:
TERMINATED
Last Update Posted:
2017-11-17
First Post:
2006-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction
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': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lkoran@stanford.edu', 'phone': '650 498 5035', 'title': 'Lorrin Koran, M.D., Professor of Psychiatry, Emeritus', 'organization': 'Stanford University Medical Center, Department of Psychiatry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Open label trial, only six subjects enrolled, only 4 completed the trial'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Duloxetine', 'description': 'Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)\n\nDuloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Global Clinical Impressions Improvement Score re Sexual Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)\n\nDuloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks'}], 'classes': [{'title': 'CGI sexual functioning much improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CGI sexual functioning minimally improved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'CGi-I sexual functioning unchanged', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CGI sexual functioning much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)', 'description': "The GCI-I score is a global clinical impression score regarding a patient's symptom severity change rated by the treating clinician. The score can be 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse). In this study clinicians made ratings based on interviewing the patient and reviewing the patient's self ratings on the the Arizona Sexual Experiences Scale (ASEX). No formal cut point scores on the ASEX were established. The ASEX is a 5-item slef rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach organism, and satisfaction from orgasm. Each item is rated from 1 to 6 (total scores from 5 to 30), with higher scores indicating greater sexual dysfunction.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Four subjects completed the study; two withdrew at end of week six. CGI-I ratings for two subjects were done at end of week 6 and this last observation was carried forward in the analysis. CGI-I ratings for the 4 completing subjects were done at end of week 12.'}, {'type': 'SECONDARY', 'title': 'Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. study duration: 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)', 'description': 'The IDS-C is a 30-item inventory designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes. Scores less than or equal to 6 indicated remission in this study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants; the last observed non-missing value was used (LOCF)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Duloxetine', 'description': 'Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)\n\nDuloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2/6 subjects withdrew at end of week 6; 1 for lack of efficacy, 1 because of time constraints.', 'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Duloxetine', 'description': 'Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. study duration: 12 weeks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': 'NA', 'comment': 'The data were destroyed some years ago, and only the mean age was preserved.', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mean age only. The data were destroyed some years ago, and only the mean age was preserved.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Antidepressant taken prior to duloxetine switch', 'classes': [{'title': 'venlafaxine', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'citalopram', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'fluoxetine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinically Depressed', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients with score \\>22 assessed by Inventory for Depressive Symptomology-Clinician Rated (IDS-C). The IDS-C is a 30-item inventory designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Adult patients taking an antidepressant drug and troubled by sexual side effects of the drug'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Unable to recruit subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-15', 'studyFirstSubmitDate': '2006-11-10', 'resultsFirstSubmitDate': '2015-04-19', 'studyFirstSubmitQcDate': '2006-11-13', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-05-30', 'studyFirstPostDateStruct': {'date': '2006-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Clinical Impressions Improvement Score re Sexual Functioning', 'timeFrame': 'baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)', 'description': "The GCI-I score is a global clinical impression score regarding a patient's symptom severity change rated by the treating clinician. The score can be 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse). In this study clinicians made ratings based on interviewing the patient and reviewing the patient's self ratings on the the Arizona Sexual Experiences Scale (ASEX). No formal cut point scores on the ASEX were established. The ASEX is a 5-item slef rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach organism, and satisfaction from orgasm. Each item is rated from 1 to 6 (total scores from 5 to 30), with higher scores indicating greater sexual dysfunction."}], 'secondaryOutcomes': [{'measure': 'Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study', 'timeFrame': 'Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)', 'description': 'The IDS-C is a 30-item inventory designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes. Scores less than or equal to 6 indicated remission in this study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors (SSRIs). The hypotheses of this study are that:1. subjects with major depression or dysthymia who are being treated with an SSRI and experiencing treatment-related sexual dysfunction will experience less sexual dysfunction if they are switched to duloxetine, and 2. they will experience either improved antidepressant response or no loss of antidepressant response.', 'detailedDescription': 'In this study, subjects suffering from depression or dysthymia and experiencing treatment-emergent sexual dysfunction from an SSRI are switched from their SSRI to duloxetine to determine whether or not they experience improved sexual function and equal or improved antidepressant response. Study subjects are assigned to receive open label duloxetine for 12 weeks at either 60mg per day or 120mg per day after discontinuing their current antidepressant'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria::\n\n* age 18 - 65 inclusive\n* able to read and understand informed consent\n* informed consent given\n* currently being treated with an SSRI for depression or dysthymia\n* currently suffering from treatment-emergent sexual dysfunction attributable to the SSRI\n* have normal safety lab values at screen\n* if currently taking medication to improve sexual performance, willing to discontinue the drug for the duration of the study\n* female subjects of child bearing age need to use an acceptable form of birth control throughout the study Exclusion Criteria:- being pregnant, breastfeeding, or planning to become pregnant within 4 months\n* suffering from psychotic, substance abuse, bipolar, or organic mental disorder, OCD, panic disorder, or personality disorder severe enough to interfere with study participation\n* suffer from an unstable or serious medical disorder\n* having a medical disorder that could be the cause of the sexual dysfunction\n* taking a medication that is metabolized by hepatic enzyme CYP2D6\n* having used a MAOI within 15 days of proposed start of duloxetine treatment\n* having a known hypersensitivity to duloxetine or any of its ingredients\n* having taken viagra or related drug within 3 months prior to starting SSRI treatment\n* requiring ongoing treatment with a mood stabilizer (anticonvulsant) or antipsychotic medication'}, 'identificationModule': {'nctId': 'NCT00398632', 'briefTitle': 'Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction', 'orgStudyIdInfo': {'id': '97143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duloxetine', 'description': 'Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)', 'interventionNames': ['Drug: Duloxetine']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['Cymbalta'], 'description': 'dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks', 'armGroupLabels': ['Duloxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Lorrin M Koran', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry, Emeritus', 'investigatorFullName': 'Lorrin M Koran', 'investigatorAffiliation': 'Stanford University'}}}}