Efficacy of Pain Treatment on Depression in Patients With Dementia

Depression Clinical Trial

— DEP-PAIN-DEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267057
• Other study ID #: NFR project nr 221951
• Secondary ID: 2013-002226-23
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2014
• Last updated: March 31, 2017
• Start date: August 2014
• Est. completion date: December 21, 2016

Study information

• Verified date: March 2017
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: December 21, 2016
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Depression
• Depressive Disorder
• Pain

Intervention

Drug:
• Paracetamol
Paracetamol granulate supplied by Weifa (Paracet) and 1 g paracetamol tablets produced by Kragerø tablettproduksjon for blinding purposes.
• Buprenorphine
Buprenorphine 5 micrograms/hour and 10 micrograms/hour transdermal system produced by Mundipharma, identical to placebo transdermal system.
• Paracetamol placebo
Paracetamol placebo tablets produced by Kragerø tablettproduksjon.
• Buprenorphine placebo
Buprenorphine transdermal system placebo produced by Mundipharma.

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the burden to personnel as measured by NPI-NH subscale		Week 0, week 6 and week 13
Primary	Change in the Cornell Scale for Depression in Dementia (CSDD)		Week -2, week 0, week 6 and week 13
Secondary	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.	Week -1 to 0 and week 12 to 13
Secondary	Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)		Week -1, week 0, week 6 and week 13
Secondary	Change in the Mini-Mental State Examination (MMSE)		Week -1 and week 13
Secondary	Change in the Mobilization- Observation - Behavior - Intensity - Dementia-2 (MOBID-2) Pain Scale		Week -1, week 0, week 6 and week 13
Secondary	Change in the Numerical Rating Scale (NRS)		Week 0, week 6 and week 13
Secondary	Change in the Quality of life in late-stage dementia (QUALID) scale		Week -1, week 0, week 6 and week 13
Secondary	Change in the EuroQoL Quality of Life Scale (EQ-5D)		Week -1, week 0, week 6 and week 13
Secondary	Adverse events (AE) and serious adverse event (SAE)	Any AE or SAE will be recorded and treated as clinically appropriate throughout the study period.	Weeks 0-13