Depression, Pain, Dementia
Conditions
Keywords
Pain measurement, Pain assessment, Pain management, Analgesia, Analgesics, Depressive symptoms, Alzheimer disease, Vascular dementia, Multi-infarct dementia, Frontotemporal lobar degeneration, Lewy body disease
Brief summary
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.
Interventions
DRUGParacetamol
Paracetamol granulate supplied by Weifa (Paracet) and 1 g paracetamol tablets produced by Kragerø tablettproduksjon for blinding purposes.
DRUGBuprenorphine
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.
DRUGBuprenorphine placebo
Buprenorphine transdermal system placebo produced by Mundipharma.
Sponsors
University of Bergen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients residing in long term nursing home units for at least 4 weeks prior to study * Diagnosed with probable or possible dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), FAST score \> 4 * Diagnosed with depression ≥ 4 week duration as measured by CSDD ≥ 8 * 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
Exclusion criteria
* The patient is contra-indicated to study drugs of pain treatment, in another trial, or had no carer. * Participants are ineligible if they are clinical critical (e.g. suicide risk) * 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 * Advanced severe medical disease/disorder with expected survival less than 6 months or that could interfere with participation * Psychosis or other severe mental disorder prior to dementia diagnosis * Severe aggression (≥8) on item 3 of the NPI subscale, with aggression as the predominant symptom * Schizophrenia, schizoaffective disorder and bipolar disorder * Uncontrolled epilepsy * Severe liver impairment * Renal failure * Severe injury or anaemia (Hb \< 8.5 mmol/l), comatose state, current enrolment in another experimental protocol * Known allergy or adverse reaction to paracetamol or buprenorphine transdermal patch * Advanced severe medical disease with expected survival of less than six months, severe psychiatric or neurological disorder. * Patients with diseases that make it impossible to follow the research schedule are excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Cornell Scale for Depression in Dementia (CSDD) | Week -2, week 0, week 6 and week 13 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in actigraphy recorded sleep patterns and circadian rhythm | Week -1 to 0 and week 12 to 13 | 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. |
| Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) | 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 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) | Weeks 0-13 | Any AE or SAE will be recorded and treated as clinically appropriate throughout the study period. |
| Change in the Numerical Rating Scale (NRS) | Week 0, week 6 and week 13 | — |
Other
| Measure | Time frame |
|---|---|
| Change in the burden to personnel as measured by NPI-NH subscale | Week 0, week 6 and week 13 |
Countries
Norway
Outcome results
None listed