Seponering av antipsykotika og antidepressiva hos demente pasienter med APSD i sykehjem - en åpen studie.

Conditions: The included patients are all elderly people with dementia of Alzheimer or vascular type. Their dementia is moderate or severe and they all have Behavioral or Psychological Symptomes (BPSD).
MedDRA version: 8.1Level: LLTClassification code 10057678Term: Vascular dementia

Registration Number: EUCTR2006-000287-84-NO

Lead Sponsor: Sykehuset Innlandet HF

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

1. Dementia of Alzheimer or vascular type.
2. BPSD
3. Regulary intake of antipsychotics or antidepressivas daily for three months or more.
4. Living in Nursing homes for the last three months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Other kind of dementia.
2. Schizofrenia, depression or another psychiatric disease.
3. Expected life-duration less than three months.
4. Terminal illness.
5. Acute infection, uncontrolled Diabetes Mellitus or another somatic disease wich may interfere with the dementia and its symptoms.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To investigate the effect of antipsychotics and antidepressivas on BPSD in patients with dementia. <br>2. To measure Quality of Life for patients with dementia before and after discontinuing antipsychotics and antidepressivas.;Secondary Objective: 1. To translate Severe Impairment Battery into Norwegian and to validate the scorings for Norwegian conditions and patients.<br>;Primary end point(s): 1. Changes in scores at the neuropsychiatric Inventory (NPI)<br>2. Changes in Extra Pyramidal side-effects.<br>3. Changes in Quality of Life registrations.<br>4. Changes in Cornell's depression scale.<br>5. Changes in body weight.<br>

Secondary Outcome Measures