Data from 162 people with advanced dementia and significant depression from 47 care homes in Norway, who were randomized to active analgesic treatment (acetaminophen/buprenorphine) or identical placebo for 13 weeks were analysed in this trial. 

The results of the DEP.PAIN. DEM trial was recently published in Clinical Interventions in Aging. 

Assistant Professor Ane Erdal, the lead author of the study, highlighted the high prevalence of adverse effects of buprenorphine transdermal system in care home residents living with moderate to severe dementia and depressive symptoms. This population also frequently showed psychiatric and neurological adverse effects with buprenorphine use. Erdal also stated, “These adverse symptoms may be challenging to identify in clinical care because they closely resemble those caused by dementing illness.” However, care home residents living with dementia are at risk for untreated pain. Thus, Erdal recommended regularly assessing pain intensity using a validated instrument in this population, and closely monitoring the potential adverse effects of the treatment.

The results from the DEP.PAIN.DEM trial also indicated a reduction in total daytime activity (objectively assessed by actigraphy) during the first days of treatment with buprenorphine transdermal system. Since reduced daytime activity is associated with a worsened prognosis, the long-term effects of buprenorphine use on daytime activity in people with dementia and chronic non-cancer related pain remain to be investigated. The research team plan on investigating whether reduced daytime activity persisted in those patients who continued treatment with buprenorphine.

Erdal also added that,  ‚ÄúAlthough nursing home patients with dementia are among those with the most complex care needs, they are rarely included in research. The design of high-quality studies is challenging because of the patients’ frail state, reduced ability to consent to participation, and the need to use proxy reports as an approximation for the patients’ subjective experience. Therefore we lack knowledge of the individual and combined effects of prescribed treatments as well as how to prioritize between different care needs in order to optimize the patient’s health and quality of life.‚Äù

Thus, Erdal is a huge proponent of conducting large-scale trials, which are highly resource-intensive and rely on the close cooperation between  researchers, care homes, health care providers, and policy makers.