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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
163
Paracetamol granulate supplied by Weifa (Paracet) and 1 g paracetamol tablets produced by Kragerø tablettproduksjon for blinding purposes.
Buprenorphine 5 micrograms/hour and 10 micrograms/hour transdermal system produced by Mundipharma, identical to placebo transdermal system.
Paracetamol placebo tablets produced by Kragerø tablettproduksjon.
University of Bergen
Bergen, Norway
Change in the Cornell Scale for Depression in Dementia (CSDD)
Time frame: Week -2, week 0, week 6 and week 13
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.
Time frame: Week -1 to 0 and week 12 to 13
Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)
Time frame: Week -1, week 0, week 6 and week 13
Change in the Mini-Mental State Examination (MMSE)
Time frame: Week -1 and week 13
Change in the Mobilization- Observation - Behavior - Intensity - Dementia-2 (MOBID-2) Pain Scale
Time frame: Week -1, week 0, week 6 and week 13
Change in the Numerical Rating Scale (NRS)
Time frame: Week 0, week 6 and week 13
Change in the Quality of life in late-stage dementia (QUALID) scale
Time frame: Week -1, week 0, week 6 and week 13
Change in the EuroQoL Quality of Life Scale (EQ-5D)
Time frame: 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.
Time frame: Weeks 0-13
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Buprenorphine transdermal system placebo produced by Mundipharma.