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Dementia Antipsychotics And Antidepressants Discontinuation Study (DESEP)

This study has been completed.
Sponsor:
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
Information provided by:
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00594269
First received: January 3, 2008
Last updated: February 22, 2011
Last verified: February 2011
History of Changes

January 3, 2008
February 22, 2011
August 2008
December 2010   (final data collection date for primary outcome measure)
  • Changes in Neuropsychiatric Inventory [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in Cornell's Depression Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in UPDRS subscale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00594269 on ClinicalTrials.gov Archive Site
  • Changes in Severe Impairment Battery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in Lawton's PADL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Oxazepam given p.n. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of falls [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in Body Weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of Life - Alzheimer disease [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Clinical Dementia Rating [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dementia Antipsychotics And Antidepressants Discontinuation Study
Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.

The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Dementia
  • Drug: Risperidone
    Discontinuation
    Other Name: ATC code N05AX 08
  • Drug: Escitalopram
    Discontinuation
    Other Name: ATC code N06AB 10
  • Drug: Citalopram
    Discontinuation
    Other Name: ATC code N06AB 04
  • Drug: Sertraline
    Discontinuation
    Other Name: ATC code N06AB 06
  • Drug: Paroxetine
    Discontinuation
    Other Name: ATC code N06AB 05
Placebo Comparator: A
Discontinuation of antipsychotic or antidepressants
Interventions:
  • Drug: Risperidone
  • Drug: Escitalopram
  • Drug: Citalopram
  • Drug: Sertraline
  • Drug: Paroxetine
Bergh S, Selbæk 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00594269
F06001
Yes
Sverre Bergh, Cand Med, Researcher., Innlandet Hospital Trust
Sykehuset Innlandet HF
  • 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
Study Chair: Knut Engedal, Ph D The Norwegian Centre for Dementia Research (NCDR), Norway
Principal Investigator: Sverre Bergh, MD Innlandet Hospital Trust, Sanderud
Sykehuset Innlandet HF
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP