Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.
Overview
- Phase
- Phase 4
- Intervention
- Risperidone
- Conditions
- Dementia
- Sponsor
- Sykehuset Innlandet HF
- Enrollment
- 149
- Locations
- 8
- Primary Endpoint
- Changes in UPDRS subscale
- Status
- Completed
- Last Updated
- 15 years ago
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 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.
Investigators
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
Arms & Interventions
A
Discontinuation of antipsychotic or antidepressants
Intervention: Risperidone
A
Discontinuation of antipsychotic or antidepressants
Intervention: Escitalopram
A
Discontinuation of antipsychotic or antidepressants
Intervention: Citalopram
A
Discontinuation of antipsychotic or antidepressants
Intervention: Sertraline
A
Discontinuation of antipsychotic or antidepressants
Intervention: Paroxetine
Outcomes
Primary Outcomes
Changes in UPDRS subscale
Time Frame: 24 weeks
Changes in Cornell's Depression Scale
Time Frame: 24 weeks
Changes in Neuropsychiatric Inventory
Time Frame: 24 weeks
Secondary Outcomes
- 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)