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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002226-23 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol or buprenorphine treatment | Active Comparator | 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. |
|
| Paracetamol placebo or buprenorphine placebo | Placebo Comparator | Paracetamol placebo tablet three times daily or buprenorphine transdermal system placebo every 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | Paracetamol granulate supplied by Weifa (Paracet) and 1 g paracetamol tablets produced by Kragerø tablettproduksjon for blinding purposes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Cornell Scale for Depression in Dementia (CSDD) | Week -2, week 0, week 6 and week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in actigraphy recorded sleep patterns and circadian rhythm | 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. | Week -1 to 0 and week 12 to 13 |
| Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the burden to personnel as measured by NPI-NH subscale | Week 0, week 6 and week 13 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina S Husebø, PhD, MD | University of Bergen | Study Director |
| Elisabeth Flo, PhD | University of Bergen | Principal Investigator |
| Ane Erdal, PhD candidate | University of Bergen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bergen | Bergen | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33189083 | Derived | 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. | |
| 29725986 | Derived | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D010146 | Pain |
| D003704 | Dementia |
| D000377 | Agnosia |
| D000544 | Alzheimer Disease |
| D015140 | Dementia, Vascular |
| D015161 | Dementia, Multi-Infarct |
| D057174 | Frontotemporal Lobar Degeneration |
| D020961 | Lewy Body Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Buprenorphine | Drug | Buprenorphine 5 micrograms/hour and 10 micrograms/hour transdermal system produced by Mundipharma, identical to placebo transdermal system. |
|
|
| Paracetamol placebo | Drug | Paracetamol placebo tablets produced by Kragerø tablettproduksjon. |
|
| Buprenorphine placebo | Drug | Buprenorphine transdermal system placebo produced by Mundipharma. |
|
| Week -1, week 0, week 6 and week 13 |
| Change in the Mini-Mental State Examination (MMSE) | Week -1 and week 13 |
| Change in the Mobilization- Observation - Behavior - Intensity - Dementia-2 (MOBID-2) Pain Scale | Week -1, week 0, week 6 and week 13 |
| Change in the Numerical Rating Scale (NRS) | Week 0, week 6 and week 13 |
| Change in the Quality of life in late-stage dementia (QUALID) scale | Week -1, week 0, week 6 and week 13 |
| Change in the EuroQoL Quality of Life Scale (EQ-5D) | Week -1, week 0, week 6 and week 13 |
| Adverse events (AE) and serious adverse event (SAE) | Any AE or SAE will be recorded and treated as clinically appropriate throughout the study period. | Weeks 0-13 |
| 29487556 | Derived | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002544 | Cerebral Infarction |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D020521 | Stroke |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| Aniline Compounds |
| D000588 | Amines |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |