Dementia Antipsychotics And Antidepressants Discontinuation Study
NCT ID: NCT00594269
Last Updated: 2011-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
149 participants
INTERVENTIONAL
2008-08-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Discontinuation of antipsychotic or antidepressants
Risperidone
Discontinuation
Escitalopram
Discontinuation
Citalopram
Discontinuation
Sertraline
Discontinuation
Paroxetine
Discontinuation
Interventions
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Risperidone
Discontinuation
Escitalopram
Discontinuation
Citalopram
Discontinuation
Sertraline
Discontinuation
Paroxetine
Discontinuation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Psychiatric disease
* Life expectancy less than 3 months
* Acute infection last 10 days
* Unstable Diabetes Mellitus
* Terminal disease
ALL
No
Sponsors
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Ullevaal University Hospital
OTHER
Eikertun Nursing Home
OTHER
University of Bergen
OTHER
Innlandet Hospital Trust, Sanderud
UNKNOWN
Innlandet Hospital Trust, Reinsvoll
UNKNOWN
Diakonhjemmet Hospital
OTHER
Sykehuset Telemark
OTHER_GOV
The Nordmøre and Romsdal Hospital Trust
UNKNOWN
Songdalstunet Nursing Home
OTHER
Sykehuset Buskerud HF
OTHER
Kroken Nursing Home, Tromsø
OTHER
Kløveråsen, Bodø
UNKNOWN
Bjørgene Omsorgssenter, Haugesund
UNKNOWN
Alesund Hospital
OTHER
Sykehuset Innlandet HF
OTHER
Responsible Party
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Innlandet Hospital Trust
Principal Investigators
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Knut Engedal, Ph D
Role: STUDY_CHAIR
The Norwegian Centre for Dementia Research (NCDR), Norway
Sverre Bergh, MD
Role: PRINCIPAL_INVESTIGATOR
Innlandet Hospital Trust, Sanderud
Locations
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Sykehuset Innlandet HF - Sanderud
Ottestad, Oppland, Norway
Sykehuset Innlandet HF
Reinsvoll, Oppland, Norway
University of Bergen, Løvaasen Nursing Home
Bergen, , Norway
Eikertun Nursing Home
Hokksund, , Norway
The Nordmøre and Romsdal Hospital Trust
Molde, , Norway
Diakonihjemmets Hospital
Oslo, , Norway
Ullevaal University Hospital
Oslo, , Norway
Telemark Hospital
Skien, , Norway
Countries
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References
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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.
Other Identifiers
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F06001
Identifier Type: -
Identifier Source: org_study_id
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