Efficacy of Pain Treatment on Depression in Patients With Dementia (DEP-PAIN-DEM)
|ClinicalTrials.gov Identifier: NCT02267057|
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depression Pain Dementia||Drug: Paracetamol Drug: Buprenorphine Drug: Paracetamol placebo Drug: Buprenorphine placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||163 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
Paracetamol granulate supplied by Weifa (Paracet) and 1 g paracetamol tablets produced by Kragerø tablettproduksjon for blinding purposes.
Other Name: Paracet (Weifa)
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.
- Change in the Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: Week -2, week 0, week 6 and week 13 ]
- 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.
- Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) [ Time Frame: Week -1, week 0, week 6 and week 13 ]
- Change in the Mini-Mental State Examination (MMSE) [ Time Frame: 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 ]
- Change in the Numerical Rating Scale (NRS) [ Time Frame: 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 ]
- Change in the EuroQoL Quality of Life Scale (EQ-5D) [ Time Frame: 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.
- Change in the burden to personnel as measured by NPI-NH subscale [ Time Frame: Week 0, week 6 and week 13 ]
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
|University of Bergen|
|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|