Clinical Trial: Efficacy of Pain Treatment on Depression in Patients With Dementia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of Bergen

Current Primary Outcome: Change in the Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: Week -2, week 0, week 6 and week 13 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University of Bergen

Dates:
Date Received: July 7, 2014
Date Started: August 2014
Date Completion:
Last Updated: March 31, 2017
Last Verified: March 2017