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Efficacy of Pain Treatment on Depression in Patients With Dementia

NCT02267057 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2017-04-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Paracetamol

Paracetamol granulate supplied by Weifa (Paracet) and 1 g paracetamol tablets produced by Kragerø tablettproduksjon for blinding purposes.

DRUG

Buprenorphine

Buprenorphine 5 micrograms/hour and 10 micrograms/hour transdermal system produced by Mundipharma, identical to placebo transdermal system.

DRUG

Paracetamol placebo

Paracetamol placebo tablets produced by Kragerø tablettproduksjon.

DRUG

Buprenorphine placebo

Buprenorphine transdermal system placebo produced by Mundipharma.

Sponsors & Collaborators

  • University of Bergen

    lead OTHER

Principal Investigators

  • Bettina S Husebø, PhD, MD · University of Bergen

  • Elisabeth Flo, PhD · University of Bergen

  • Ane Erdal, PhD candidate · University of Bergen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-12-21
Completion
2016-12-21

Countries

  • Norway

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02267057 on ClinicalTrials.gov