Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-25 @ 2:59 AM
Study NCT ID:
NCT01575158
Status:
COMPLETED
Last Update Posted:
2012-04-11
First Post:
2012-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Citalopram vs Clomipramine vs Placebo in Recurrent Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D015283', 'term': 'Citalopram'}, {'id': 'D002997', 'term': 'Clomipramine'}], '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': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-10', 'studyFirstSubmitDate': '2012-04-10', 'studyFirstSubmitQcDate': '2012-04-10', 'lastUpdatePostDateStruct': {'date': '2012-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2 Hamilton Depression Rating Scale scores of at least 16 with one weeks interval or initiation of another antidepressant treatment', 'timeFrame': '2 years of follow-up'}], 'secondaryOutcomes': [{'measure': 'Study termination due to adverse event or non-compliance', 'timeFrame': '2 years of follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'citalopram and clomipramine are better than placebo in preventing new episodes of depression in patients with recurrent depression'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with recurrent depression\n* Sustained response achieved (3 consecutive monthly ratings at the HDS below 13)after a treatment requiring index episode\n\nExclusion Criteria:\n\n* Contraindications to study medications\n* Pregnancy\n* Substance abuse'}, 'identificationModule': {'nctId': 'NCT01575158', 'briefTitle': 'Citalopram vs Clomipramine vs Placebo in Recurrent Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'orgStudyIdInfo': {'id': 'DUAG-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'citalopram', 'description': 'citalopram', 'interventionNames': ['Drug: Citalopram']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'clomipramnine', 'description': 'clomipramine', 'interventionNames': ['Drug: Clomipramine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Citalopram', 'type': 'DRUG', 'armGroupLabels': ['citalopram']}, {'name': 'Clomipramine', 'type': 'DRUG', 'armGroupLabels': ['clomipramnine']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish University Antidepressant Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}