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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-000287-84-NO
Enrollment
24
Registered
2006-05-15
Start date
2006-07-11
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 8.1 Level: LLT Classification code 10057678 Term: Vascular dementia

Interventions

Sponsors

Sykehuset Innlandet HF
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: 1. To investigate the effect of antipsychotics and antidepressivas on BPSD in patients with dementia. 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. ;Primary end point(s): 1. Changes in scores at the neuropsychiatric Inventory (NPI) 2. Changes in Extra Pyramidal side-effects. 3. Changes in Quality of Life registrations. 4. Changes in Cornell's depression scale. 5. Changes in body weight.

Countries

Norway

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026