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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02267057
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Bettina Husebo, University of Bergen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depression Pain Dementia Drug: Paracetamol Drug: Buprenorphine Drug: Paracetamol placebo Drug: Buprenorphine placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Pain Treatment on Depression in Patients With Dementia. A Randomized Clinical Trial.
Study Start Date : August 2014
Actual Primary Completion Date : December 21, 2016
Actual Study Completion Date : December 21, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: Paracet (Weifa)

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


Outcome Measures
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Primary Outcome Measures :
  1. Change in the Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: Week -2, week 0, week 6 and week 13 ]

Secondary Outcome Measures :
  1. 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.

  2. Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) [ Time Frame: Week -1, week 0, week 6 and week 13 ]
  3. Change in the Mini-Mental State Examination (MMSE) [ Time Frame: Week -1 and week 13 ]
  4. Change in the Mobilization- Observation - Behavior - Intensity - Dementia-2 (MOBID-2) Pain Scale [ Time Frame: Week -1, week 0, week 6 and week 13 ]
  5. Change in the Numerical Rating Scale (NRS) [ Time Frame: Week 0, week 6 and week 13 ]
  6. Change in the Quality of life in late-stage dementia (QUALID) scale [ Time Frame: Week -1, week 0, week 6 and week 13 ]
  7. Change in the EuroQoL Quality of Life Scale (EQ-5D) [ Time Frame: Week -1, week 0, week 6 and week 13 ]
  8. 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.


Other Outcome Measures:
  1. Change in the burden to personnel as measured by NPI-NH subscale [ Time Frame: Week 0, week 6 and week 13 ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267057


Locations
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Norway
University of Bergen
Bergen, Norway
Sponsors and Collaborators
University of Bergen
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bettina Husebo, MD, assoc prof. University of Bergen, University of Bergen
ClinicalTrials.gov Identifier: NCT02267057    
Other Study ID Numbers: NFR project nr 221951
2013-002226-23 ( EudraCT Number )
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Keywords provided by Bettina Husebo, University of Bergen:
Pain measurement
Pain assessment
Pain management
Analgesia
Analgesics
Depressive symptoms
 Alzheimer disease
Vascular dementia
Multi-infarct dementia
Frontotemporal lobar degeneration
Lewy body disease
Additional relevant MeSH terms:
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Dementia
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Acetaminophen
 Buprenorphine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Narcotic Antagonists