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Completed

NCT Number: NCT02267057

Efficacy of Pain Treatment on Depression in Patients With Dementia

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.

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Key information

Conditions

Depression Agnosia Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Dementia Dementia, Multi-Infarct Dementia, Vascular Frontotemporal Lobar Degeneration Infarction Intracranial Arterial Diseases Intracranial Arteriosclerosis Ischemia Leukoencephalopathies Lewy Body Disease Mental Disorders Metabolic Diseases Movement Disorders Necrosis Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Proteostasis Deficiencies Signs and Symptoms Stroke Synucleinopathies TDP-43 Proteinopathies Tauopathies Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Bergen

Bergen, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

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

Other names: Paracet (Weifa)

buprenorphine

Drug

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

Other names: Norspan (Mundipharma)

Paracetamol Placebo

Drug

Paracetamol placebo tablets produced by Kragerø tablettproduksjon.

Buprenorphine placebo

Drug

Buprenorphine transdermal system placebo produced by Mundipharma.

Primary outcomes

  1. Change in the Cornell Scale for Depression in Dementia (CSDD)

    Time frame: Week -2, week 0, week 6 and week 13

Secondary outcomes

  1. Change in actigraphy recorded sleep patterns and circadian rhythm

    Time frame: 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.

  2. Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)

    Time frame: Week -1, week 0, week 6 and week 13

  3. Change in the Mini-Mental State Examination (MMSE)

    Time frame: Week -1 and week 13

  4. Change in the Mobilization- Observation - Behavior - Intensity - Dementia-2 (MOBID-2) Pain Scale

    Time frame: Week -1, week 0, week 6 and week 13

  5. Change in the Numerical Rating Scale (NRS)

    Time frame: Week 0, week 6 and week 13

  6. Change in the Quality of life in late-stage dementia (QUALID) scale

    Time frame: Week -1, week 0, week 6 and week 13

  7. Change in the EuroQoL Quality of Life Scale (EQ-5D)

    Time frame: Week -1, week 0, week 6 and week 13

  8. Adverse events (AE) and serious adverse event (SAE)

    Time frame: Weeks 0-13

    Any AE or SAE will be recorded and treated as clinically appropriate throughout the study period.

Other outcomes

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

    Time frame: Week 0, week 6 and week 13

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

Efficacy of Pain Treatment on Depression in Patients With Dementia. A Randomized Clinical Trial.

Acronym: DEP-PAIN-DEM

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2014
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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