← Trials/Trial dossier/NCT02267057

DEP-PAIN-DEM

CompletedPhase 4

Efficacy of Pain Treatment on Depression in Patients With Dementia

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

Lead sponsor

University of Bergen

Assets

Acetaminophen / Buprenorphine

Listed sites

Recruiting sites

Enrollment

163

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age ≥60

Primary endpoint

•The Cornell Scale for Depression in Dementia (CSDD)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2013-002226-23

NCT IDNCT02267057

Org study IDNFR project nr 221951

Timeline

Milestones

Study start2014-08 (month precision)

Study first posted2014-10-17estimated

Primary completion2016-12-21actual

Study completion2016-12-21actual

Last update posted2017-04-04actual

Assets

Drug assets

Acetaminophen Buprenorphine

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Caregiver / quality of life

Global cognition

Safety / tolerability / PK

Other (unclassified)

Global cognition

1 endpoint

Secondary/protocol endpoint

Change in the Mini-Mental State Examination (MMSE)

Time frame:Week -1 and week 13

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Behavior / neuropsychiatric

5 endpoints

Primary/protocol endpoint

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

Time frame:Week -2, week 0, week 6 and week 13

change from baseline, improvement

Secondary/protocol endpoint

Change in actigraphy recorded sleep patterns and circadian rhythm

Time frame:Week -1 to 0 and week 12 to 13

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week -1, week 0, week 6 and week 13

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

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 from baseline, improvement

Other/protocol endpoint

Change in the burden to personnel as measured by NPI-NH subscale

Time frame:Week 0, week 6 and week 13

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

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

Time frame:Week -1, week 0, week 6 and week 13

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week -1, week 0, week 6 and week 13

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

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

Time frame:Weeks 0-13

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in the Numerical Rating Scale (NRS)

Time frame:Week 0, week 6 and week 13

change from baseline, improvement

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.