Dementia Antipsychotics And Antidepressants Discontinuation Study - Tabular View

Tracking Information

First Received Date ^ICMJE

January 3, 2008

Last Updated Date

October 7, 2009

Start Date ^ICMJE

August 2008

Estimated 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 ] [ 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 ]

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 ] [ 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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Dementia

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Placebo Comparator: Discontinuation of antipsychotic or antidepressants

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

212

Estimated Completion Date

December 2010

Estimated 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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sverre Bergh, MB

+47 45 67 93 93

sverre.bergh@sykehuset-innlandet.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00594269

Responsible Party

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

Study ID Numbers ^ICMJE

F06001

Study Sponsor ^ICMJE

Sykehuset Innlandet HF

Collaborators ^ICMJE

Ullevaal University Hospital
Eikertun Nursing Home
University of Bergen, Løvaasen nursing Home
Innlandet Hospital Trust, Sanderud
Innlandet Hospital Trust, Reinsvoll
Diakonihjemmet Hospital
Telemark Hospital
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

Information Provided By

Sykehuset Innlandet HF

Verification Date

October 2009

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