Efficacy of Pain Treatment on Depression in Patients With Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-12-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression Pain Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paracetamol or buprenorphine treatment

Paracetamol tablets 1 g three times daily or Buprenorphine transdermal system 5 micrograms/hour every 7 days, may be titrated up to 10 micrograms/hour every 7 days if clinically appropriate.

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

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

Buprenorphine

Intervention Type DRUG

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

Paracetamol placebo or buprenorphine placebo

Paracetamol placebo tablet three times daily or buprenorphine transdermal system placebo every 7 days.

Group Type PLACEBO_COMPARATOR

Paracetamol placebo

Intervention Type DRUG

Paracetamol placebo tablets produced by Kragerø tablettproduksjon.

Buprenorphine placebo

Intervention Type DRUG

Buprenorphine transdermal system placebo produced by Mundipharma.

Interventions

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Paracetamol

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

Intervention Type DRUG

Buprenorphine

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

Intervention Type DRUG

Paracetamol placebo

Paracetamol placebo tablets produced by Kragerø tablettproduksjon.

Intervention Type DRUG

Buprenorphine placebo

Buprenorphine transdermal system placebo produced by Mundipharma.

Intervention Type DRUG

Other Intervention Names

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Paracet (Weifa) Norspan (Mundipharma)

Eligibility Criteria

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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

Exclusion Criteria

* The patient is contra-indicated to study drugs of pain treatment, in another trial, or had no carer.
* Participants are ineligible if they are clinical critical (e.g. suicide risk)
* 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
* Severe liver impairment
* Renal failure
* Severe injury or anaemia (Hb \< 8.5 mmol/l), comatose state, current enrolment in another experimental protocol
* Known allergy or adverse reaction to paracetamol or buprenorphine transdermal patch
* Advanced severe medical disease with expected survival of less than six months, severe psychiatric or neurological disorder.
* Patients with diseases that make it impossible to follow the research schedule are excluded

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No