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

March 31, 2017 updated by: Bettina Husebo, University of Bergen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
163

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • University of Bergen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: Paracetamol
Paracetamol granulate supplied by Weifa (Paracet) and 1 g paracetamol tablets produced by Kragerø tablettproduksjon for blinding purposes.
Other Names:
  • Paracet (Weifa)
Drug: Buprenorphine
Buprenorphine 5 micrograms/hour and 10 micrograms/hour transdermal system produced by Mundipharma, identical to placebo transdermal system.
Other Names:
  • Norspan (Mundipharma)
Placebo Comparator: Paracetamol placebo or buprenorphine placebo
Paracetamol placebo tablet three times daily or buprenorphine transdermal system placebo every 7 days.
Drug: Paracetamol placebo
Paracetamol placebo tablets produced by Kragerø tablettproduksjon.
Drug: Buprenorphine placebo
Buprenorphine transdermal system placebo produced by Mundipharma.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in the Cornell Scale for Depression in Dementia (CSDD)
Time Frame: Week -2, week 0, week 6 and week 13
Week -2, week 0, week 6 and week 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in actigraphy recorded sleep patterns and circadian rhythm
Time Frame: Week -1 to 0 and week 12 to 13
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.
Week -1 to 0 and week 12 to 13
Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)
Time Frame: Week -1, week 0, week 6 and week 13
Week -1, week 0, week 6 and week 13
Change in the Mini-Mental State Examination (MMSE)
Time Frame: Week -1 and week 13
Week -1 and week 13
Change in the Mobilization- Observation - Behavior - Intensity - Dementia-2 (MOBID-2) Pain Scale
Time Frame: Week -1, week 0, week 6 and week 13
Week -1, week 0, week 6 and week 13
Change in the Numerical Rating Scale (NRS)
Time Frame: Week 0, week 6 and week 13
Week 0, week 6 and week 13
Change in the Quality of life in late-stage dementia (QUALID) scale
Time Frame: Week -1, week 0, week 6 and week 13
Week -1, week 0, week 6 and week 13
Change in the EuroQoL Quality of Life Scale (EQ-5D)
Time Frame: Week -1, week 0, week 6 and week 13
Week -1, week 0, week 6 and week 13
Adverse events (AE) and serious adverse event (SAE)
Time Frame: Weeks 0-13
Any AE or SAE will be recorded and treated as clinically appropriate throughout the study period.
Weeks 0-13

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change in the burden to personnel as measured by NPI-NH subscale
Time Frame: Week 0, week 6 and week 13
Week 0, week 6 and week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bergen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bettina S Husebø, PhD, MD, University of Bergen
  • Principal Investigator: Elisabeth Flo, PhD, University of Bergen
  • Principal Investigator: Ane Erdal, PhD candidate, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFR project nr 221951
  • 2013-002226-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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