Efficacy of Pain Treatment on Depression in Patients With Dementia

NCT02267057 | Completed Phase 4 DMC

• 2 other identifiers: NFR project nr 2219512013-002226-23
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in the Cornell Scale for Depression in Dementia (CSDD)

  Week -2, week 0, week 6 and week 13

Secondary Outcomes (8)

• Change in actigraphy recorded sleep patterns and circadian rhythm

  Week -1 to 0 and week 12 to 13

• 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 Numerical Rating Scale (NRS)

  Week 0, week 6 and week 13

Other Outcomes (1)

• Change in the burden to personnel as measured by NPI-NH subscale

  Week 0, week 6 and week 13

Study Arms (2)

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.

Drug: Paracetamol; Drug: Buprenorphine

Paracetamol placebo or buprenorphine placebo

PLACEBO COMPARATOR

Paracetamol placebo tablet three times daily or buprenorphine transdermal system placebo every 7 days.

Drug: Paracetamol placebo; Drug: Buprenorphine placebo

Interventions

Paracetamol DRUG

Paracetamol granulate supplied by Weifa (Paracet) and 1 g paracetamol tablets produced by Kragerø tablettproduksjon for blinding purposes.

Also known as: Paracet (Weifa)

Paracetamol or buprenorphine treatment

Buprenorphine DRUG

Buprenorphine 5 micrograms/hour and 10 micrograms/hour transdermal system produced by Mundipharma, identical to placebo transdermal system.

Also known as: Norspan (Mundipharma)

Paracetamol or buprenorphine treatment

Paracetamol placebo DRUG

Paracetamol placebo tablets produced by Kragerø tablettproduksjon.

Paracetamol placebo or buprenorphine placebo

Buprenorphine placebo DRUG

Buprenorphine transdermal system placebo produced by Mundipharma.

Paracetamol placebo or buprenorphine placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

University of Bergen

Bergen, Norway

Location

Related Publications (3)

• 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.

  PMID: 33189083 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.

  PMID: 29725986 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.

  PMID: 29487556 DERIVED

MeSH Terms

Conditions

Depression; Pain; Dementia; Agnosia; Alzheimer Disease; Dementia, Vascular; Dementia, Multi-Infarct; Frontotemporal Lobar Degeneration; Lewy Body Disease

Interventions

Acetaminophen; Buprenorphine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Infarction; Brain Infarction; Brain Ischemia; Stroke; Infarction; Ischemia; Pathologic Processes; Necrosis; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, assoc prof. University of Bergen

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: October 17, 2014
• Study Start: August 1, 2014
• Primary Completion: December 21, 2016
• Study Completion: December 21, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

NO (1)