Dementia Antipsychotics And Antidepressants Discontinuation Study - Full Text View

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
Information provided by:	Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:	NCT00594269

Purpose

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

Condition	Intervention	Phase
Dementia	Drug: Risperidone Drug: Escitalopram Drug: Citalopram Drug: Sertraline Drug: Paroxetine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Dementia Nursing Homes

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Paroxetine Paroxetine hydrochloride Sertraline hydrochloride Sertraline Risperidone Paroxetine hydrochloride hemihydrate Escitalopram Paroxetine Mesylate Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Sykehuset Innlandet HF:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	149
Study Start Date:	August 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: A Discontinuation of antipsychotic or antidepressants	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

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594269

Locations

Norway
Sykehuset Innlandet HF - Sanderud
Ottestad, Oppland, Norway, 2312
Sykehuset Innlandet HF
Reinsvoll, Oppland, Norway, 2840
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

Sponsors and Collaborators

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

Investigators

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

More Information

No publications provided

Responsible Party:	Sverre Bergh, Cand Med, Researcher., Innlandet Hospital Trust
ClinicalTrials.gov Identifier:	NCT00594269 History of Changes
Other Study ID Numbers:	F06001
Study First Received:	January 3, 2008
Last Updated:	February 22, 2011
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway

Keywords provided by Sykehuset Innlandet HF:

Antidepressants
Antipsychotics
Dementia
Discontinuation study
Behavioural- and Psychological Symptoms in Dementia

Additional relevant MeSH terms:

Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Paroxetine
Sertraline
Dexetimide
Risperidone
Antipsychotic Agents
Psychotropic Drugs
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists

ClinicalTrials.gov processed this record on February 09, 2012