Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD
Information source: Sykehuset Innlandet HF
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dementia
Intervention: Risperidone (Drug); Olanzapine (Drug); Haloperidole (Drug); Quetiapin (Drug); Escitalopram (Drug); Citalopram (Drug); Sertralin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sykehuset Innlandet HF Official(s) and/or principal investigator(s):
Knut Engedal, Ph D, Study Chair, Affiliation: The Norwegian Centre for Dementia Research (NCDR), Norway
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).
Clinical Details
Official title: Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Changes in Neuropsychiatric InventoryChanges in weight Changes in Cornell's Depression Scale Changes in UPDRS subscale Changes in "Quality of Live - Alzheimer Disease"
Secondary outcome: Changes in Severe Impairment BatteryChanges in Lawton's PADL Oxazepam given p.n. Drop outs
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 in use, despite its lack of clinical evidence.
We will discontinue antipsychotics in one group of 12 patients and antidepressants in one
group of 12 patients. 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 an open labelled study with no control group. Based on the results of this study, we
will design a RCT study with placebo-controlled group.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sykehuset Innlandet HF - Sanderud, Ottestad, Oppland 2312, Norway
Additional Information
Starting date: September 2006
Ending date: August 2007
Last updated: August 23, 2007
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