Effect of Pain Treatment on Depression in Patients with Dementia

Phase 1

• Conditions: DepressionPainDementia; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-002226-23-NO
• Lead Sponsor: niversity of Bergen, Department of Global Public Health and Primary Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-12
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified