Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433121
Status:
COMPLETED
Last Update Posted:
2007-08-24
First Post:
2007-02-01
Brief Title:
Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD
Sponsor:
Sykehuset Innlandet HF
Organization:
Sykehuset Innlandet HF
Study Overview
Official Title:
Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None