Discontinuation of antipsychotic and antidepressant in patients with dementia and BPSD living in nursing homes. A placebo controlled RCT.

Introduction: The prevalence of patients with dementia is high and many of them have Behavioral- and Psychological Symptoms in Dementia (BPSD). Treatments for BPSD are non-medical or medical therapy. Antipsychotic medication, acetylchollinesterase inhibi tors and antidepressant medication are all used for the treatment of BPSD. None of them have shown great effect on BPSD, but they are widely used for patients with BPSD. Study design/inclusion/exclusion: We will conduct a placebo controlled RCT with 21 2 patients. 60 patients will be in the antipsychotic withdrawal group, 152 patients in the antidepressant withdrawal group. Half of the patients will be randomised to continue their medication, half will be randomised to placebo. All patients have Alzheim er- or vascular dementia and they have been prescribed antipsychotics or antidepressants for 3 months or more. All patients have been living in nursing homes for the last 3 months. None of the patients included in the study will have severe psychiatric di sease, terminal illness or severe somatic illness. The medication will be tapered out over a period of one week. The study period is 24 weeks. The patients, who are able to give their consent, will sign a written consent form. For patients not able to giv e their consent, relatives will be informed and they may deny inclusion. The DESEP study will cooperate with more than 11 studycenters across Norway. Method: The patients will be tested with the Neuropsychiatric Inventory (NPI), Clinical Dementia Rating Scale (CDR), Severe Impairment Battery (SIB), Quality of Life - Alzheimer Disease (QoL-AD), Cornell's depression scale, Lawton's PADL and Unified Parkinson Disease Rating Scale (UPDRS) Publication and approvals: The study will be published in an internat ional journal. The study is approved by The Regional Committee of Medical Research Ethics, SH-dir and Personvernombudet UUS. Application is sent to the Norwegian Medicines Agency.