Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT02267057
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02267057
Study Brief:
Protocol Section:
NCT02267057