Back to resultsDiscontinuation of Antipsychotics and Antidepressants Among Patients With BPSD
Primary Purpose
Dementia
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Risperidone
Olanzapine
Haloperidole
Quetiapin
Escitalopram
Citalopram
Sertralin
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Antidepressive Agents, Neuroleptica, Dementia, Discontinuation study, Behavioural- and Psychological Symptoms in Dementia
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
Sites / Locations
- Sykehuset Innlandet HF - Sanderud
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Discontinuation of neuroleptic or anti depressants
Outcomes
Primary Outcome Measures
Changes in Neuropsychiatric Inventory
Changes in weight
Changes in Cornell's Depression Scale
Changes in UPDRS subscale
Changes in "Quality of Live - Alzheimer Disease"
Secondary Outcome Measures
Changes in Severe Impairment Battery
Changes in Lawton's PADL
Oxazepam given p.n.
Drop outs
Full Information
NCT ID
NCT00433121
First Posted
February 1, 2007
Last Updated
August 23, 2007
Sponsor
Sykehuset Innlandet HF
Collaborators
Demensforbundet, Norway
1. Study Identification
Unique Protocol Identification Number
NCT00433121
Brief Title
Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD
Official Title
Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sykehuset Innlandet HF
Collaborators
Demensforbundet, Norway
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Antidepressive Agents, Neuroleptica, Dementia, Discontinuation study, Behavioural- and Psychological Symptoms in Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Discontinuation of neuroleptic or anti depressants
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Type
Drug
Intervention Name(s)
Haloperidole
Intervention Type
Drug
Intervention Name(s)
Quetiapin
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Type
Drug
Intervention Name(s)
Citalopram
Intervention Type
Drug
Intervention Name(s)
Sertralin
Primary Outcome Measure Information:
Title
Changes in Neuropsychiatric Inventory
Time Frame
24 weeks
Title
Changes in weight
Time Frame
24 weeks
Title
Changes in Cornell's Depression Scale
Time Frame
24 weeks
Title
Changes in UPDRS subscale
Time Frame
24 weeks
Title
Changes in "Quality of Live - Alzheimer Disease"
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Changes in Severe Impairment Battery
Time Frame
24 weeks
Title
Changes in Lawton's PADL
Time Frame
24 weeks
Title
Oxazepam given p.n.
Time Frame
24 weeks
Title
Drop outs
Time Frame
24 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Engedal, Ph D
Organizational Affiliation
The Norwegian Centre for Dementia Research (NCDR), Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Sykehuset Innlandet HF - Sanderud
City
Ottestad
State/Province
Oppland
ZIP/Postal Code
2312
Country
Norway
12. IPD Sharing Statement
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Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD
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