Clinical trial NCT02267057: Efficacy of Pain Treatment on Depression in Patients With Dementia
Official title: Efficacy of Pain Treatment on Depression in Patients With Dementia. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Pain
Dementia
Keywords: Pain measurement
Pain assessment
Pain management
Analgesia
Analgesics
Depressive symptoms
Alzheimer disease
Vascular dementia
Multi-infarct dementia
Frontotemporal lobar degeneration
Lewy body disease
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 163
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Cornell Scale for Depression in Dementia (CSDD)
timeFrame: Week -2, week 0, week 6 and week 13
Secondary outcomes:
measure: Change in actigraphy recorded sleep patterns and circadian rhythm
timeFrame: Week -1 to 0 and week 12 to 13
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
Other outcomes:
measure: Change in the burden to personnel as measured by NPI-NH subscale
timeFrame: Week 0, week 6 and week 13
Locations:
city: Bergen
country: Norway
facility: University of Bergen
Study officials:
affiliation: University of Bergen
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
References:
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.
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.
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.