Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).

Detailed Description
-----------------
Patients with dementia have cognitive deficits, but also hallucinations, delusions, agitation, aggression and apathy. These symptoms are called Behavioural- and Psychological Symptoms in Dementia (BPSD), and are difficult to treat. Antipsychotic and antidepressant medication is in use, despite its lack of clinical evidence. We will discontinue antipsychotics in one group of 12 patients and antidepressants in one group of 12 patients. Patients should have dementia of Alzheimer- or vascular origin. They should live in Nursing Homes and have no other psychiatric disease for which they receive psychotropic drug. They will be registered with 7 different questionnaires at baseline and after 3, 6, 12 and 24 weeks. The study period is 24 weeks. The questionnaires are filled in by the patients and the nurses at the nursing homes. This is an open labelled study with no control group. Based on the results of this study, we will design a RCT study with placebo-controlled group.

Official Title
-----------------
Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study.

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Drug: Risperidone
* Drug: Olanzapine
* Drug: Haloperidole
* Drug: Quetiapin
* Drug: Escitalopram
* Drug: Citalopram
* Drug: Sertralin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vascular- or Alzheimer Dementia Nursing Homes resident for 3 months or more Given antipsychotics or antidepressants for 3 months or more Clinical Dementia rating 1, 2 or 3 Exclusion Criteria: Dementia of other origin Psychiatric disease Life expectancy less than 3 months Acute infection last 10 days Unstable Diabetes Mellitus Terminal disease
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Discontinuation of neuroleptic or anti depressants | Drug: Risperidone<br> <br> Drug: Olanzapine<br> <br> Drug: Haloperidole<br> <br> Drug: Quetiapin<br> <br> Drug: Escitalopram<br> <br> Drug: Citalopram<br> <br> Drug: Sertralin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Neuropsychiatric Inventory |  | 24 weeks | 
| Changes in weight |  | 24 weeks | 
| Changes in Cornell's Depression Scale |  | 24 weeks | 
| Changes in UPDRS subscale |  | 24 weeks | 
| Changes in Quality of Live - Alzheimer Disease |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Severe Impairment Battery |  | 24 weeks | 
| Changes in Lawton's PADL |  | 24 weeks | 
| Oxazepam given p.n. |  | 24 weeks | 
| Drop outs |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antidepressive Agents, Neuroleptica, Dementia, Discontinuation study, Behavioural- and Psychological Symptoms in Dementia