Trial | NCT00594269  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    149
The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).
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.
Study Started
Aug 31
2008
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2010
Last Update
Feb 23
2011
Estimate

Drug Risperidone

Discontinuation

  • Other names: ATC code N05AX 08

Drug Escitalopram

Discontinuation

  • Other names: ATC code N06AB 10

Drug Citalopram

Discontinuation

  • Other names: ATC code N06AB 04

Drug Sertraline

Discontinuation

  • Other names: ATC code N06AB 06

Drug Paroxetine

Discontinuation

  • Other names: ATC code N06AB 05

A Placebo Comparator

Discontinuation of antipsychotic or antidepressants

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
No Results Posted