Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT02267057
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2014-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Pain Treatment on Depression in Patients With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D015161', 'term': 'Dementia, Multi-Infarct'}, {'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2014-07-07', 'studyFirstSubmitQcDate': '2014-10-16', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in the burden to personnel as measured by NPI-NH subscale', 'timeFrame': 'Week 0, week 6 and week 13'}], 'primaryOutcomes': [{'measure': 'Change in the Cornell Scale for Depression in Dementia (CSDD)', 'timeFrame': 'Week -2, week 0, week 6 and week 13'}], 'secondaryOutcomes': [{'measure': 'Change in actigraphy recorded sleep patterns and circadian rhythm', 'timeFrame': 'Week -1 to 0 and week 12 to 13', 'description': 'Actigraph will be used for a period of 1 week before study treatment starts, and in the last week of treatment, on a selection of patients in the placebo group and in the treatment group.'}, {'measure': 'Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)', 'timeFrame': 'Week -1, week 0, week 6 and week 13'}, {'measure': 'Change in the Mini-Mental State Examination (MMSE)', 'timeFrame': 'Week -1 and week 13'}, {'measure': 'Change in the Mobilization- Observation - Behavior - Intensity - Dementia-2 (MOBID-2) Pain Scale', 'timeFrame': 'Week -1, week 0, week 6 and week 13'}, {'measure': 'Change in the Numerical Rating Scale (NRS)', 'timeFrame': 'Week 0, week 6 and week 13'}, {'measure': 'Change in the Quality of life in late-stage dementia (QUALID) scale', 'timeFrame': 'Week -1, week 0, week 6 and week 13'}, {'measure': 'Change in the EuroQoL Quality of Life Scale (EQ-5D)', 'timeFrame': 'Week -1, week 0, week 6 and week 13'}, {'measure': 'Adverse events (AE) and serious adverse event (SAE)', 'timeFrame': 'Weeks 0-13', 'description': 'Any AE or SAE will be recorded and treated as clinically appropriate throughout the study period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain measurement', 'Pain assessment', 'Pain management', 'Analgesia', 'Analgesics', 'Depressive symptoms', 'Alzheimer disease', 'Vascular dementia', 'Multi-infarct dementia', 'Frontotemporal lobar degeneration', 'Lewy body disease'], 'conditions': ['Depression', 'Pain', 'Dementia']}, 'referencesModule': {'references': [{'pmid': '33189083', 'type': 'DERIVED', 'citation': 'McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.'}, {'pmid': '29725986', 'type': 'DERIVED', 'citation': 'Erdal A, Flo E, Aarsland D, Ballard C, Slettebo DD, Husebo BS. Efficacy and Safety of Analgesic Treatment for Depression in People with Advanced Dementia: Randomised, Multicentre, Double-Blind, Placebo-Controlled Trial (DEP.PAIN.DEM). Drugs Aging. 2018 Jun;35(6):545-558. doi: 10.1007/s40266-018-0546-2.'}, {'pmid': '29487556', 'type': 'DERIVED', 'citation': 'Blytt KM, Husebo B, Flo E, Bjorvatn B. Long-Term Pain Treatment Did Not Improve Sleep in Nursing Home Patients with Comorbid Dementia and Depression: A 13-Week Randomized Placebo-Controlled Trial. Front Psychol. 2018 Feb 13;9:134. doi: 10.3389/fpsyg.2018.00134. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether pain treatment can reduce symptoms of depression in patients suffering from dementia and depression. Depression is commonly diagnosed in patients with dementia. If the investigators find a reduction in depressive symptoms when pain treatment is applied, this will support the hypothesis that undiagnosed pain may present itself as depression in patients with dementia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients residing in long term nursing home units for at least 4 weeks prior to study\n* Diagnosed with probable or possible dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), FAST score \\> 4\n* Diagnosed with depression ≥ 4 week duration as measured by CSDD ≥ 8\n* Written, informed consent provided by the participant (if they have capacity) or assent (if they do not have capacity) and a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant\n\nExclusion Criteria:\n\n* The patient is contra-indicated to study drugs of pain treatment, in another trial, or had no carer.\n* Participants are ineligible if they are clinical critical (e.g. suicide risk)\n* Clinician responsible for care, or study clinician considers that the patient suffers from any physical condition, which would make participation in the trial distressing or likely to increase suffering\n* Advanced severe medical disease/disorder with expected survival less than 6 months or that could interfere with participation\n* Psychosis or other severe mental disorder prior to dementia diagnosis\n* Severe aggression (≥8) on item 3 of the NPI subscale, with aggression as the predominant symptom\n* Schizophrenia, schizoaffective disorder and bipolar disorder\n* Uncontrolled epilepsy\n* Severe liver impairment\n* Renal failure\n* Severe injury or anaemia (Hb \\< 8.5 mmol/l), comatose state, current enrolment in another experimental protocol\n* Known allergy or adverse reaction to paracetamol or buprenorphine transdermal patch\n* Advanced severe medical disease with expected survival of less than six months, severe psychiatric or neurological disorder.\n* Patients with diseases that make it impossible to follow the research schedule are excluded'}, 'identificationModule': {'nctId': 'NCT02267057', 'acronym': 'DEP-PAIN-DEM', 'briefTitle': 'Efficacy of Pain Treatment on Depression in Patients With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Bergen'}, 'officialTitle': 'Efficacy of Pain Treatment on Depression in Patients With Dementia. A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'NFR project nr 221951'}, 'secondaryIdInfos': [{'id': '2013-002226-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paracetamol or buprenorphine treatment', 'description': 'Paracetamol tablets 1 g three times daily or Buprenorphine transdermal system 5 micrograms/hour every 7 days, may be titrated up to 10 micrograms/hour every 7 days if clinically appropriate.', 'interventionNames': ['Drug: Paracetamol', 'Drug: Buprenorphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Paracetamol placebo or buprenorphine placebo', 'description': 'Paracetamol placebo tablet three times daily or buprenorphine transdermal system placebo every 7 days.', 'interventionNames': ['Drug: Paracetamol placebo', 'Drug: Buprenorphine placebo']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'otherNames': ['Paracet (Weifa)'], 'description': 'Paracetamol granulate supplied by Weifa (Paracet) and 1 g paracetamol tablets produced by Kragerø tablettproduksjon for blinding purposes.', 'armGroupLabels': ['Paracetamol or buprenorphine treatment']}, {'name': 'Buprenorphine', 'type': 'DRUG', 'otherNames': ['Norspan (Mundipharma)'], 'description': 'Buprenorphine 5 micrograms/hour and 10 micrograms/hour transdermal system produced by Mundipharma, identical to placebo transdermal system.', 'armGroupLabels': ['Paracetamol or buprenorphine treatment']}, {'name': 'Paracetamol placebo', 'type': 'DRUG', 'description': 'Paracetamol placebo tablets produced by Kragerø tablettproduksjon.', 'armGroupLabels': ['Paracetamol placebo or buprenorphine placebo']}, {'name': 'Buprenorphine placebo', 'type': 'DRUG', 'description': 'Buprenorphine transdermal system placebo produced by Mundipharma.', 'armGroupLabels': ['Paracetamol placebo or buprenorphine placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'facility': 'University of Bergen', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Bettina S Husebø, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Bergen'}, {'name': 'Elisabeth Flo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bergen'}, {'name': 'Ane Erdal, PhD candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bergen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bergen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, assoc prof. University of Bergen', 'investigatorFullName': 'Bettina Husebo', 'investigatorAffiliation': 'University of Bergen'}}}}