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

Tracking Information

First Received Date ^ICMJE

January 3, 2008

Last Updated Date

February 22, 2011

Start Date ^ICMJE

August 2008

Primary Completion Date

December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in Neuropsychiatric Inventory [ Time Frame: 24 weeks ]
Changes in Cornell's Depression Scale [ Time Frame: 24 weeks ]
Changes in UPDRS subscale [ Time Frame: 24 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00594269 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in Severe Impairment Battery [ Time Frame: 24 weeks ]
Changes in Lawton's PADL [ Time Frame: 24 weeks ]
Oxazepam given p.n. [ Time Frame: 24 weeks ]
Number of falls [ Time Frame: 24 weeks ]
Changes in Body Weight [ Time Frame: 24 weeks ]
Quality of Life - Alzheimer disease [ Time Frame: 24 weeks ]
Clinical Dementia Rating [ Time Frame: 24 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Dementia Antipsychotics And Antidepressants Discontinuation Study

Official Title ^ICMJE

Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Dementia

Intervention ^ICMJE

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

Study Arms

Placebo Comparator: A

Discontinuation of antipsychotic or antidepressants

Interventions:

Drug: Risperidone
Drug: Escitalopram
Drug: Citalopram
Drug: Sertraline
Drug: Paroxetine

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

149

Completion Date

December 2010

Primary Completion Date

December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Norway

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00594269

Other Study ID Numbers ^ICMJE

F06001

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Sverre Bergh, Cand Med, Researcher., Innlandet Hospital Trust

Study Sponsor ^ICMJE

Sykehuset Innlandet HF

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Chair:	Knut Engedal, Ph D	The Norwegian Centre for Dementia Research (NCDR), Norway
Principal Investigator:	Sverre Bergh, MD	Innlandet Hospital Trust, Sanderud

PRS Account

Sykehuset Innlandet HF

Verification Date

February 2011

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

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