Dementia Antipsychotics And Antidepressants Discontinuation Study (DESEP)
Primary Purpose
Dementia
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Risperidone
Escitalopram
Citalopram
Sertraline
Paroxetine
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Antidepressants, Antipsychotics, 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
- Sykehuset Innlandet HF
- University of Bergen, Løvaasen Nursing Home
- Eikertun Nursing Home
- The Nordmøre and Romsdal Hospital Trust
- Diakonihjemmets Hospital
- Ullevaal University Hospital
- Telemark Hospital
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
A
Arm Description
Discontinuation of antipsychotic or antidepressants
Outcomes
Primary Outcome Measures
Changes in Neuropsychiatric Inventory
Changes in Cornell's Depression Scale
Changes in UPDRS subscale
Secondary Outcome Measures
Changes in Severe Impairment Battery
Changes in Lawton's PADL
Oxazepam given p.n.
Number of falls
Changes in Body Weight
Quality of Life - Alzheimer disease
Clinical Dementia Rating
Full Information
NCT ID
NCT00594269
First Posted
January 3, 2008
Last Updated
February 22, 2011
Sponsor
Sykehuset Innlandet HF
Collaborators
Ullevaal University Hospital, Eikertun Nursing Home, University of Bergen, Innlandet Hospital Trust, Sanderud, Innlandet Hospital Trust, Reinsvoll, Diakonhjemmet Hospital, Sykehuset Telemark, The Nordmøre and Romsdal Hospital Trust, Songdalstunet Nursing Home, Sykehuset Buskerud HF, Kroken Nursing Home, Tromsø, Kløveråsen, Bodø, Bjørgene Omsorgssenter, Haugesund, Alesund Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00594269
Brief Title
Dementia Antipsychotics And Antidepressants Discontinuation Study
Acronym
DESEP
Official Title
Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sykehuset Innlandet HF
Collaborators
Ullevaal University Hospital, Eikertun Nursing Home, University of Bergen, Innlandet Hospital Trust, Sanderud, Innlandet Hospital Trust, Reinsvoll, Diakonhjemmet Hospital, Sykehuset Telemark, The Nordmøre and Romsdal Hospital Trust, Songdalstunet Nursing Home, Sykehuset Buskerud HF, Kroken Nursing Home, Tromsø, Kløveråsen, Bodø, Bjørgene Omsorgssenter, Haugesund, Alesund Hospital
4. Oversight
Data Monitoring Committee
Yes
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 used as treatment, despite its lack of clinical evidence.
We will discontinue risperidone in one group of 30 patients and compere them to 30 controls and we will discontinue antidepressants in a group of 76 patients and compere them to 76 controls. 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 a double blind 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
Antidepressants, Antipsychotics, Dementia, Discontinuation study, Behavioural- and Psychological Symptoms in Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Discontinuation of antipsychotic or antidepressants
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
ATC code N05AX 08
Intervention Description
Discontinuation
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
ATC code N06AB 10
Intervention Description
Discontinuation
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
ATC code N06AB 04
Intervention Description
Discontinuation
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
ATC code N06AB 06
Intervention Description
Discontinuation
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Other Intervention Name(s)
ATC code N06AB 05
Intervention Description
Discontinuation
Primary Outcome Measure Information:
Title
Changes in Neuropsychiatric Inventory
Time Frame
24 weeks
Title
Changes in Cornell's Depression Scale
Time Frame
24 weeks
Title
Changes in UPDRS subscale
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
Number of falls
Time Frame
24 weeks
Title
Changes in Body Weight
Time Frame
24 weeks
Title
Quality of Life - Alzheimer disease
Time Frame
24 weeks
Title
Clinical Dementia Rating
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
First Name & Middle Initial & Last Name & Degree
Sverre Bergh, MD
Organizational Affiliation
Innlandet Hospital Trust, Sanderud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset Innlandet HF - Sanderud
City
Ottestad
State/Province
Oppland
ZIP/Postal Code
2312
Country
Norway
Facility Name
Sykehuset Innlandet HF
City
Reinsvoll
State/Province
Oppland
ZIP/Postal Code
2840
Country
Norway
Facility Name
University of Bergen, Løvaasen Nursing Home
City
Bergen
Country
Norway
Facility Name
Eikertun Nursing Home
City
Hokksund
Country
Norway
Facility Name
The Nordmøre and Romsdal Hospital Trust
City
Molde
Country
Norway
Facility Name
Diakonihjemmets Hospital
City
Oslo
Country
Norway
Facility Name
Ullevaal University Hospital
City
Oslo
Country
Norway
Facility Name
Telemark Hospital
City
Skien
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
22408266
Citation
Bergh S, Selbaek G, Engedal K. Discontinuation of antidepressants in people with dementia and neuropsychiatric symptoms (DESEP study): double blind, randomised, parallel group, placebo controlled trial. BMJ. 2012 Mar 9;344:e1566. doi: 10.1136/bmj.e1566.
Results Reference
derived
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Dementia Antipsychotics And Antidepressants Discontinuation Study
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