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Efficacy of Pain Treatment on Depression in Patients With Dementia (DEP-PAIN-DEM)

Primary Purpose

Depression, Pain, Dementia

Status

Completed

Phase

Phase 4

Locations

Norway

Study Type

Interventional

Intervention

Paracetamol

Buprenorphine

Paracetamol placebo

Buprenorphine placebo

About this trial

This is an interventional treatment trial for Depression focused on measuring Pain measurement, Pain assessment, Pain management, Analgesia, Analgesics, Depressive symptoms, Alzheimer disease, Vascular dementia, Multi-infarct dementia, Frontotemporal lobar degeneration, Lewy body disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

University of Bergen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Paracetamol or buprenorphine treatment

Paracetamol placebo or buprenorphine placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in the Cornell Scale for Depression in Dementia (CSDD)

Secondary Outcome Measures

Change in actigraphy recorded sleep patterns and circadian rhythm

Actigraph will be used for a period of 1 week before study treatment starts, and in the last week of treatment, on a selection of patients in the placebo group and in the treatment group.

Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)

Change in the Mini-Mental State Examination (MMSE)

Change in the Mobilization- Observation - Behavior - Intensity - Dementia-2 (MOBID-2) Pain Scale

Change in the Numerical Rating Scale (NRS)

Change in the Quality of life in late-stage dementia (QUALID) scale

Change in the EuroQoL Quality of Life Scale (EQ-5D)

Adverse events (AE) and serious adverse event (SAE)

Any AE or SAE will be recorded and treated as clinically appropriate throughout the study period.

Full Information

NCT ID

NCT02267057

First Posted

July 7, 2014

Last Updated

March 31, 2017

Sponsor

University of Bergen

1. Study Identification

Unique Protocol Identification Number

NCT02267057

Brief Title

Efficacy of Pain Treatment on Depression in Patients With Dementia

Acronym

DEP-PAIN-DEM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

December 21, 2016 (Actual)

Study Completion Date

December 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Bergen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Pain, Dementia

Keywords

Pain measurement, Pain assessment, Pain management, Analgesia, Analgesics, Depressive symptoms, Alzheimer disease, Vascular dementia, Multi-infarct dementia, Frontotemporal lobar degeneration, Lewy body disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

163 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paracetamol or buprenorphine treatment

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Paracetamol placebo or buprenorphine placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Paracetamol

Other Intervention Name(s)

Paracet (Weifa)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Buprenorphine

Other Intervention Name(s)

Norspan (Mundipharma)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paracetamol placebo

Intervention Description

Paracetamol placebo tablets produced by Kragerø tablettproduksjon.

Intervention Type

Drug

Intervention Name(s)

Buprenorphine placebo

Intervention Description

Buprenorphine transdermal system placebo produced by Mundipharma.

Primary Outcome Measure Information:

Title

Change in the Cornell Scale for Depression in Dementia (CSDD)

Time Frame

Week -2, week 0, week 6 and week 13

Secondary Outcome Measure Information:

Title

Change in actigraphy recorded sleep patterns and circadian rhythm

Description

Actigraph will be used for a period of 1 week before study treatment starts, and in the last week of treatment, on a selection of patients in the placebo group and in the treatment group.

Time Frame

Week -1 to 0 and week 12 to 13

Title

Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)

Time Frame

Week -1, week 0, week 6 and week 13

Title

Change in the Mini-Mental State Examination (MMSE)

Time Frame

Week -1 and week 13

Title

Change in the Mobilization- Observation - Behavior - Intensity - Dementia-2 (MOBID-2) Pain Scale

Time Frame

Week -1, week 0, week 6 and week 13

Title

Change in the Numerical Rating Scale (NRS)

Time Frame

Week 0, week 6 and week 13

Title

Change in the Quality of life in late-stage dementia (QUALID) scale

Time Frame

Week -1, week 0, week 6 and week 13

Title

Change in the EuroQoL Quality of Life Scale (EQ-5D)

Time Frame

Week -1, week 0, week 6 and week 13

Title

Adverse events (AE) and serious adverse event (SAE)

Description

Any AE or SAE will be recorded and treated as clinically appropriate throughout the study period.

Time Frame

Weeks 0-13

Other Pre-specified Outcome Measures:

Title

Change in the burden to personnel as measured by NPI-NH subscale

Time Frame

Week 0, week 6 and week 13

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bettina S Husebø, PhD, MD

Organizational Affiliation

University of Bergen

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Elisabeth Flo, PhD

Organizational Affiliation

University of Bergen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ane Erdal, PhD candidate

Organizational Affiliation

University of Bergen

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Bergen

City

Bergen

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

33189083

Citation

McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.

Results Reference

derived

PubMed Identifier

29725986

Citation

Erdal A, Flo E, Aarsland D, Ballard C, Slettebo DD, Husebo BS. Efficacy and Safety of Analgesic Treatment for Depression in People with Advanced Dementia: Randomised, Multicentre, Double-Blind, Placebo-Controlled Trial (DEP.PAIN.DEM). Drugs Aging. 2018 Jun;35(6):545-558. doi: 10.1007/s40266-018-0546-2.

Results Reference

derived

PubMed Identifier

29487556

Citation

Blytt KM, Husebo B, Flo E, Bjorvatn B. Long-Term Pain Treatment Did Not Improve Sleep in Nursing Home Patients with Comorbid Dementia and Depression: A 13-Week Randomized Placebo-Controlled Trial. Front Psychol. 2018 Feb 13;9:134. doi: 10.3389/fpsyg.2018.00134. eCollection 2018.

Results Reference

derived

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Efficacy of Pain Treatment on Depression in Patients With Dementia

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