AzTrials
AzTrials

DepressionPhase 4DEP-PAIN-DEMNCT02267057

Efficacy of Pain Treatment on Depression in Patients With Dementia

A Phase 4 study testing Paracetamol and Buprenorphine in people with Depression and Pain, run by University of Bergen at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Depression, Pain, Dementia
What is being tested?
Paracetamol and Buprenorphine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
163 participants
Where
1 siteNorway
Study dates
Aug 2014to 21 Dec 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • University of Bergen

    Bergen

Other trials in Norway

About this study

Official title: 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.

Being tested
Paracetamol, Buprenorphine, Paracetamol placebo, Buprenorphine placebo
Keywords
Pain measurement, Pain assessment, Pain management, Analgesia, Analgesics, Depressive symptoms, Alzheimer disease, Vascular dementia, Multi-infarct dementia, Frontotemporal lobar degeneration, Lewy body disease
Medical subject headings
Depression, Pain, Dementia, Agnosia, Alzheimer Disease, Dementia, Vascular, Dementia, Multi-Infarct, Frontotemporal Lobar Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ParacetamolDrug

    Also called Paracet (Weifa)

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

  • BuprenorphineDrug

    Also called Norspan (Mundipharma)

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

  • Paracetamol placeboDrug

    Paracetamol placebo tablets produced by Kragerø tablettproduksjon.

  • Buprenorphine placeboDrug

    Buprenorphine transdermal system placebo produced by Mundipharma.

Study groups in NCT02267057
Study groupRoleWhat they receive
Paracetamol or buprenorphine treatmentActive comparatorParacetamol 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.
Receives: Drug: Paracetamol; Drug: Buprenorphine
Paracetamol placebo or buprenorphine placeboPlacebo comparatorParacetamol placebo tablet three times daily or buprenorphine transdermal system placebo every 7 days.
Receives: Drug: Paracetamol placebo; Drug: Buprenorphine placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (8)

  1. 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.

    Measured: Week -1 to 0 and week 12 to 13

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

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

  3. Change in the Mini-Mental State Examination (MMSE)

    Measured: Week -1 and week 13

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

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

  5. Change in the Numerical Rating Scale (NRS)

    Measured: Week 0, week 6 and week 13

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

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

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

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

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

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

    Measured: Weeks 0-13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2014 (estimated)
  2. Study startAug 2014
  3. Primary completion21 Dec 2016
  4. Study completion21 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02267057
Sponsor's protocol ID
NFR project nr 221951
Other IDs
2013-002226-23
Acronym
DEP-PAIN-DEM
Status last verified
Mar 2017
First submitted
7 Jul 2014
Last updated
4 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33189083

  • 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.

    PubMed 29725986

  • 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.

    PubMed 29487556

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paracetamol and Buprenorphine in people with Depression and Pain, run by University of Bergen at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Cornell Scale for Depression in Dementia (CSDD) (time frame: Week -2, week 0, week 6 and week 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02267057, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in