Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-31 @ 12:13 PM
Study NCT ID:
NCT00594269
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
2008-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dementia Antipsychotics And Antidepressants Discontinuation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D015283', 'term': 'Citalopram'}, {'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-22', 'studyFirstSubmitDate': '2008-01-03', 'studyFirstSubmitQcDate': '2008-01-03', 'lastUpdatePostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Neuropsychiatric Inventory', 'timeFrame': '24 weeks'}, {'measure': "Changes in Cornell's Depression Scale", 'timeFrame': '24 weeks'}, {'measure': 'Changes in UPDRS subscale', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in Severe Impairment Battery', 'timeFrame': '24 weeks'}, {'measure': "Changes in Lawton's PADL", 'timeFrame': '24 weeks'}, {'measure': 'Oxazepam given p.n.', 'timeFrame': '24 weeks'}, {'measure': 'Number of falls', 'timeFrame': '24 weeks'}, {'measure': 'Changes in Body Weight', 'timeFrame': '24 weeks'}, {'measure': 'Quality of Life - Alzheimer disease', 'timeFrame': '24 weeks'}, {'measure': 'Clinical Dementia Rating', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Antidepressants', 'Antipsychotics', 'Dementia', 'Discontinuation study', 'Behavioural- and Psychological Symptoms in Dementia'], 'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '22408266', 'type': 'DERIVED', 'citation': 'Bergh S, Selbaek G, Engedal K. Discontinuation of antidepressants in people with dementia and neuropsychiatric symptoms (DESEP study): double blind, randomised, parallel group, placebo controlled trial. BMJ. 2012 Mar 9;344:e1566. doi: 10.1136/bmj.e1566.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).', 'detailedDescription': 'Patients with dementia have cognitive deficits, but also hallucinations, delusions, agitation, aggression and apathy. These symptoms are called Behavioural- and Psychological Symptoms in Dementia (BPSD), and are difficult to treat. Antipsychotic and antidepressant medication is used as treatment, despite its lack of clinical evidence.\n\nWe will discontinue risperidone in one group of 30 patients and compere them to 30 controls and we will discontinue antidepressants in a group of 76 patients and compere them to 76 controls. Patients should have dementia of Alzheimer- or vascular origin. They should live in Nursing Homes and have no other psychiatric disease for which they receive psychotropic drug. They will be registered with 7 different questionnaires at baseline and after 3, 6, 12 and 24 weeks. The study period is 24 weeks. The questionnaires are filled in by the patients and the nurses at the nursing homes.\n\nThis is a double blind RCT study with placebo-controlled group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vascular- or Alzheimer Dementia\n* Nursing Homes resident for 3 months or more\n* Given antipsychotics or antidepressants for 3 months or more\n* Clinical Dementia rating 1, 2 or 3\n\nExclusion Criteria:\n\n* Dementia of other origin\n* Psychiatric disease\n* Life expectancy less than 3 months\n* Acute infection last 10 days\n* Unstable Diabetes Mellitus\n* Terminal disease'}, 'identificationModule': {'nctId': 'NCT00594269', 'acronym': 'DESEP', 'briefTitle': 'Dementia Antipsychotics And Antidepressants Discontinuation Study', 'organization': {'class': 'OTHER', 'fullName': 'Sykehuset Innlandet HF'}, 'officialTitle': 'Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.', 'orgStudyIdInfo': {'id': 'F06001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'description': 'Discontinuation of antipsychotic or antidepressants', 'interventionNames': ['Drug: Risperidone', 'Drug: Escitalopram', 'Drug: Citalopram', 'Drug: Sertraline', 'Drug: Paroxetine']}], 'interventions': [{'name': 'Risperidone', 'type': 'DRUG', 'otherNames': ['ATC code N05AX 08'], 'description': 'Discontinuation', 'armGroupLabels': ['A']}, {'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['ATC code N06AB 10'], 'description': 'Discontinuation', 'armGroupLabels': ['A']}, {'name': 'Citalopram', 'type': 'DRUG', 'otherNames': ['ATC code N06AB 04'], 'description': 'Discontinuation', 'armGroupLabels': ['A']}, {'name': 'Sertraline', 'type': 'DRUG', 'otherNames': ['ATC code N06AB 06'], 'description': 'Discontinuation', 'armGroupLabels': ['A']}, {'name': 'Paroxetine', 'type': 'DRUG', 'otherNames': ['ATC code N06AB 05'], 'description': 'Discontinuation', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2312', 'city': 'Ottestad', 'state': 'Oppland', 'country': 'Norway', 'facility': 'Sykehuset Innlandet HF - Sanderud', 'geoPoint': {'lat': 60.74743, 'lon': 11.1366}}, {'zip': '2840', 'city': 'Reinsvoll', 'state': 'Oppland', 'country': 'Norway', 'facility': 'Sykehuset Innlandet HF', 'geoPoint': {'lat': 60.67977, 'lon': 10.62175}}, {'city': 'Bergen', 'country': 'Norway', 'facility': 'University of Bergen, Løvaasen Nursing Home', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Hokksund', 'country': 'Norway', 'facility': 'Eikertun Nursing Home', 'geoPoint': {'lat': 59.77077, 'lon': 9.90987}}, {'city': 'Molde', 'country': 'Norway', 'facility': 'The Nordmøre and Romsdal Hospital Trust', 'geoPoint': {'lat': 62.73752, 'lon': 7.15912}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Diakonihjemmets Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Ullevaal University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Skien', 'country': 'Norway', 'facility': 'Telemark Hospital', 'geoPoint': {'lat': 59.20962, 'lon': 9.60897}}], 'overallOfficials': [{'name': 'Knut Engedal, Ph D', 'role': 'STUDY_CHAIR', 'affiliation': 'The Norwegian Centre for Dementia Research (NCDR), Norway'}, {'name': 'Sverre Bergh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Innlandet Hospital Trust, Sanderud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, {'name': 'Eikertun Nursing Home', 'class': 'OTHER'}, {'name': 'University of Bergen', 'class': 'OTHER'}, {'name': 'Innlandet Hospital Trust, Sanderud', 'class': 'UNKNOWN'}, {'name': 'Innlandet Hospital Trust, Reinsvoll', 'class': 'UNKNOWN'}, {'name': 'Diakonhjemmet Hospital', 'class': 'OTHER'}, {'name': 'Sykehuset Telemark', 'class': 'OTHER_GOV'}, {'name': 'The Nordmøre and Romsdal Hospital Trust', 'class': 'UNKNOWN'}, {'name': 'Songdalstunet Nursing Home', 'class': 'OTHER'}, {'name': 'Sykehuset Buskerud HF', 'class': 'OTHER'}, {'name': 'Kroken Nursing Home, Tromsø', 'class': 'OTHER'}, {'name': 'Kløveråsen, Bodø', 'class': 'UNKNOWN'}, {'name': 'Bjørgene Omsorgssenter, Haugesund', 'class': 'UNKNOWN'}, {'name': 'Alesund Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Sverre Bergh, Cand Med, Researcher.', 'oldOrganization': 'Innlandet Hospital Trust'}}}}