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Efficacy of Pain Treatment on Depression in Patients With Dementia | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Efficacy of Pain Treatment on Depression in Patients With Dementia

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

NCT02267057•University of Bergen

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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

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
•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
+6 more criteria

Exclusion Criteria

•The patient is contra-indicated to study drugs of pain treatment, in another trial, or had no carer.

Locations (1)

University of Bergen

Bergen, Norway

Key Dates

Start Date

August 1, 2014

Primary Completion Date

December 21, 2016

Completion Date

December 21, 2016

Last Updated

April 4, 2017

Enrollment

163

ACTUAL participants

Conditions

DepressionPainDementia

Interventions

Paracetamol

DRUG

Buprenorphine

DRUG

Paracetamol placebo

DRUG

Buprenorphine placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy of Pain Treatment on Depression in Patients With Dementia

Inclusion Criteria

Exclusion Criteria

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