Efficacy of Pain Treatment on Depression in Patients With Dementia

Overview

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.

Full Title of Study: “Efficacy of Pain Treatment on Depression in Patients With Dementia. A Randomized Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 21, 2016

Interventions

  • Drug: Paracetamol
    • Paracetamol granulate supplied by Weifa (Paracet) and 1 g paracetamol tablets produced by Kragerø tablettproduksjon for blinding purposes.
  • Drug: Buprenorphine
    • Buprenorphine 5 micrograms/hour and 10 micrograms/hour transdermal system produced by Mundipharma, identical to placebo transdermal system.
  • Drug: Paracetamol placebo
    • Paracetamol placebo tablets produced by Kragerø tablettproduksjon.
  • Drug: Buprenorphine placebo
    • Buprenorphine transdermal system placebo produced by Mundipharma.

Arms, Groups and Cohorts

  • Active Comparator: Paracetamol or buprenorphine treatment
    • 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.
  • Placebo Comparator: Paracetamol placebo or buprenorphine placebo
    • Paracetamol placebo tablet three times daily or buprenorphine transdermal system placebo every 7 days.

Clinical Trial Outcome Measures

Primary Measures

  • Change in the Cornell Scale for Depression in Dementia (CSDD)
    • Time Frame: Week -2, week 0, week 6 and week 13

Secondary Measures

  • 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.
  • Change in the Neuropsychiatric Inventory – Nursing Home Version (NPI-NH)
    • Time Frame: Week -1, week 0, week 6 and week 13
  • Change in the Mini-Mental State Examination (MMSE)
    • Time Frame: Week -1 and week 13
  • Change in the Mobilization- Observation – Behavior – Intensity – Dementia-2 (MOBID-2) Pain Scale
    • Time Frame: Week -1, week 0, week 6 and week 13
  • Change in the Numerical Rating Scale (NRS)
    • Time Frame: Week 0, week 6 and week 13
  • Change in the Quality of life in late-stage dementia (QUALID) scale
    • Time Frame: Week -1, week 0, week 6 and week 13
  • Change in the EuroQoL Quality of Life Scale (EQ-5D)
    • Time Frame: Week -1, week 0, week 6 and week 13
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Bergen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bettina Husebo, MD, assoc prof. University of Bergen – University of Bergen
  • Overall Official(s)
    • Bettina S Husebø, PhD, MD, Study Director, University of Bergen
    • Elisabeth Flo, PhD, Principal Investigator, University of Bergen
    • Ane Erdal, PhD candidate, Principal Investigator, University of Bergen

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