Depression Pain Dementia
Conditions
Interventions
Trade Name: Paracet
Product Name: Paracet
Product Code: N02B E01
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name:
Sponsors
University of Bergen, Department of Global Public Health and Primary Care
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will conduct a multicentre, parallel-group, 13-week double-blind, placebo-controlled RCT of participants from 38 nursing homes in Bergen, Stavanger, Sogn og Fjordane, Oslo and Bærum. Participants Participants (N=266) are eligible if they are 60 years and older and have probable or possible dementia, in accordance to the National Institute of Neurological and Communicative Diseases and Stroke (NINCDS) – Alzheimer`s Disease and Related Disorders Association (ADRDA) and coexisting depression (= 4 weeks` duration) that was assessed as potentially needing antidepressants or despite ongoing treatment with antidepressant. A research worker will assess depression severity with the CSDD,9 with eligible participants scoring = 8. Participants are ineligible if they are clinical critical (e.g. suicide risk), contraindicated to study drugs of pain treatment, in another trial, or had no carer. Study design allows ongoing treatment with antidepressant if remained stable for 4 weeks prior to study inclusion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 266
Exclusion criteria
Exclusion criteria: Exclusion criteria will be advanced severe medical disease with expected survival of less than six months, severe psychiatric or neurological disorder, severe aggression (agitation score = 8 on the NPI-NH, 24 with aggression as the predominant symptom).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main-goal Explore whether pain management can improve depression in patients with dementia ;Secondary Objective: Sub-goals a)Explore the relationship between pain and depression in dementia. b)Explore the relationship of pain measurements (pain diagnoses, -intensity, -location) with frequency and severity of depression in patients at different levels of dementia c)Explore the relationship between different grades of pain and grades of depression, anxiety, sadness, appetite, or pessimism, i.e. which depressive symptoms are associated with pain d)Explore the relationship between different grades of pain treatment and severity of depression in patients with dementia ;Primary end point(s): Primary and secondary outcomes will be collected at baseline, week 6 and 13. Primary outcome measure is the CSDD, validated among persons with and without dementia. Each of the 19 items is rated from 0 (no symptom) to 2 (severe). CSDD allows rating: “symptom impossible to evaluate”. Depression is defined as a score = 8; mild depression as a score 8-11 and moderate–severe depression >12. Inter-rater reliability (0.73–1.00) and validity were examined and suggested to be satisfactory. Correlation coefficients of CSDD sum scores were high. ;Timepoint(s) of evaluation of this end point: At baseline, week 6 and 13 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome measures o Neuropsychiatric Inventory-Nursing Home version, NPI-NH, a caregiver based interview, assessing delusion, hallucination, agitation, depression, anxiety, disinhibition, apathy, irritability, aberrant motor activity, sleep, appetite. Total and subscale scores are provided with frequency, severity, and caregiver’s distress (total score 1-144). o In a series of studies, our research group developed and tested a pain measurement, Mobilization– Observation – Behavior – Intensity – Dementia-2 Pain Scale (MOBID-2), a nurse-administered pain tool for dementia, which assesses pain intensity related to internal organs, head and skin based on pain behaviours. Good kappa agreements are shown for pain behaviour and -drawings. Inter-rater and test-retest reliability, and Cronbach’s a for pain intensity is high. o Numerical Rating Scale (NRS) is a 0-10 horizontal scale (0=no pain, 10=as bad as possible). If possible, patients will be asked whether they are in pain at that moment (yes/no) and then asked to complete to score any pain experienced at that time by NRS. o Activities of Daily Living (ADL) assess physical function. Rating includes activities like feeding, moving, personal toilet, and dressing higher values indicating higher levels of activities of daily functioning and independency. The scale includes 10 items (0-20 score). o Mini-Mental State Examination (MMSE), enables cut-off differentiation for levels of dementia severity (0-11=severe, 12-17=moderate, 18-23=mild, 24-30=no impairment). o HQoL will be assessed by DEMQoL (28 items), a new tool appropriate for use at all stages of dementia severity, available in self- and proxy-report version. o UKU safety scale to investigate side effects in treatment with antidepressant. Safety and tolerability assessments will record all adverse events (AE) and serious adverse events (SAE) and vital signs at each assessment. ;Timepoint(s) of evaluation of this end point: At base | — |
Countries
Norway
Contacts
Public ContactFri prosjectstøtte for medisin
Norwegin Research Council
Outcome results
None listed