Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-26 @ 4:49 AM
Study NCT ID:
NCT00047450
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2002-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antidepressant Treatment in Older Adults With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015283', 'term': 'Citalopram'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2002-10-04', 'studyFirstSubmitQcDate': '2002-10-04', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Psychotic Disorders'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '20361918', 'type': 'DERIVED', 'citation': 'Zisook S, Kasckow JW, Lanouette NM, Golshan S, Fellows I, Vahia I, Mohamed S, Rao S. Augmentation with citalopram for suicidal ideation in middle-aged and older outpatients with schizophrenia and schizoaffective disorder who have subthreshold depressive symptoms: a randomized controlled trial. J Clin Psychiatry. 2010 Jul;71(7):915-22. doi: 10.4088/JCP.09m05699gre. Epub 2010 Mar 9.'}, {'pmid': '19192468', 'type': 'DERIVED', 'citation': 'Zisook S, Kasckow JW, Golshan S, Fellows I, Solorzano E, Lehman D, Mohamed S, Jeste DV. Citalopram augmentation for subsyndromal symptoms of depression in middle-aged and older outpatients with schizophrenia and schizoaffective disorder: a randomized controlled trial. J Clin Psychiatry. 2009 Apr;70(4):562-71. doi: 10.4088/jcp.08m04261. Epub 2008 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of citalopram (Celexa) for the treatment of depressive symptoms in middle-aged and elderly patients with schizophrenia.', 'detailedDescription': 'Older people with schizophrenia suffer from greater physical comorbidity, cognitive impairment, and medication side effects compared to their younger counterparts. Unfortunately, little research is available to guide the treatment of subsyndromal depressive symptoms in older adults. This study will compare the antidepressant citalopram to placebo to determine the most effective treatment for reducing depressive symptoms in older patients with schizophrenia\n\nAfter patients have been on stable treatment with antipsychotic medication for at least 4 weeks, they are randomly assigned to receive antipsychotic medication plus either citalopram or placebo for 3 months. Depressive symptoms and side effects are assessed weekly for the first month, biweekly for the second month, and again at the end of the third month. Cognition, motor and daily functioning, quality of life, and medication adherence are assessed throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia or schizoaffective disorder\n* HAM-D score of 8 or above\n* Antipsychotic medication treatment'}, 'identificationModule': {'nctId': 'NCT00047450', 'briefTitle': 'Antidepressant Treatment in Older Adults With Schizophrenia', 'nctIdAliases': ['NCT00046098'], 'organization': {'class': 'OTHER', 'fullName': 'Veterans Medical Research Foundation'}, 'officialTitle': 'Citalopram Augmentation in Older Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'R01MH063931', 'link': 'https://reporter.nih.gov/quickSearch/R01MH063931', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH063931', 'link': 'https://reporter.nih.gov/quickSearch/R01MH063931', 'type': 'NIH'}, {'id': 'DATR A4-GPX'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Participants will take placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants will take citalopram (Celexa)', 'interventionNames': ['Drug: Citalopram (Celexa)']}], 'interventions': [{'name': 'Citalopram (Celexa)', 'type': 'DRUG', 'description': 'Citalopram for 3 months', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for 3 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego VA Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Veterans Administration Hospital of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Sidney Zisook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Veterans Medical Research Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Sidney Zisook', 'investigatorAffiliation': 'Veterans Medical Research Foundation'}}}}