Efficacy of Pain Treatment on Depression in Patients with Dementia. A Randomized Clinical Trial of Efficacy - DEP.PAIN.DEM

niversity of Bergen, Department of Global Public Health and Primary Care0 sites266 target enrollmentNovember 12, 2013

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity of Bergen, Department of Global Public Health and Primary Care
Enrollment: 266
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

November 12, 2013

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Bergen, Department of Global Public Health and Primary Care

•We will conduct a multicentre, parallel\-group, 13\-week double\-blind, placebo\-controlled RCT of participants from 38 nursing homes in Bergen, Stavanger, Sogn og Fjordane, Oslo and Bærum.
•Participants
•Participants (N\=266\) are eligible if they are 60 years and older and have probable or possible dementia, in accordance to the National Institute of Neurological and Communicative Diseases and Stroke (NINCDS) – Alzheimer\`s Disease and Related Disorders Association (ADRDA) and coexisting depression (\= 4 weeks\` duration) that was assessed as potentially needing antidepressants or despite ongoing treatment with antidepressant. A research worker will assess depression severity with the CSDD,9 with eligible participants scoring \= 8\. Participants are ineligible if they are clinical critical (e.g. suicide risk), contraindicated to study drugs of pain treatment, in another trial, or had no carer. Study design allows ongoing treatment with antidepressant if remained stable for 4 weeks prior to study inclusion.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 266

•Exclusion criteria will be advanced severe medical disease with expected survival of less than six months, severe psychiatric or neurological disorder, severe aggression (agitation score \= 8 on the NPI\-NH, 24 with aggression as the predominant symptom).