Dementia Antipsychotics And Antidepressants Discontinuation Study

Study Overview
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Brief Summary
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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
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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 used as treatment, despite its lack of clinical evidence. We will discontinue risperidone in one group of 30 patients and compere them to 30 controls and we will discontinue antidepressants in a group of 76 patients and compere them to 76 controls. 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 a double blind RCT study with placebo-controlled group.

Official Title
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Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.

Conditions
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Dementia

Intervention / Treatment
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* Drug: Risperidone
* Drug: Escitalopram
* Drug: Citalopram
* Drug: Sertraline
* Drug: Paroxetine


Participation Criteria
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Eligibility Criteria
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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
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Discontinuation of antipsychotic or antidepressants | Drug: Risperidone<br>* Discontinuation<br>* Other names: ATC code N05AX 08;Drug: Escitalopram<br>* Discontinuation<br>* Other names: ATC code N06AB 10;Drug: Citalopram<br>* Discontinuation<br>* Other names: ATC code N06AB 04;Drug: Sertraline<br>* Discontinuation<br>* Other names: ATC code N06AB 06;Drug: Paroxetine<br>* Discontinuation<br>* Other names: ATC code N06AB 05;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Neuropsychiatric Inventory |  | 24 weeks | 
| Changes in Cornell's Depression Scale |  | 24 weeks | 
| Changes in UPDRS subscale |  | 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 | 
| Number of falls |  | 24 weeks | 
| Changes in Body Weight |  | 24 weeks | 
| Quality of Life - Alzheimer disease |  | 24 weeks | 
| Clinical Dementia Rating |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antidepressants, Antipsychotics, Dementia, Discontinuation study, Behavioural- and Psychological Symptoms in Dementia