Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD - Full Text View

Sponsor:	Sykehuset Innlandet HF
Collaborator:	Demensforbundet, Norway
Information provided by:	Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:	NCT00433121

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: Olanzapine Drug: Haloperidole Drug: Quetiapin Drug: Escitalopram Drug: Citalopram Drug: Sertralin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study.

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Dementia

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Risperidone Escitalopram Olanzapine 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 ]
Changes in weight [ Time Frame: 24 weeks ]
Changes in Cornell's Depression Scale [ Time Frame: 24 weeks ]
Changes in UPDRS subscale [ Time Frame: 24 weeks ]
Changes in "Quality of Live - Alzheimer Disease" [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

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 ]
Drop outs [ Time Frame: 24 weeks ]

Enrollment:	24
Study Start Date:	September 2006
Study Completion Date:	August 2007

Arms	Assigned Interventions
A: Experimental Discontinuation of neuroleptic or anti depressants	Drug: Risperidone Drug: Olanzapine Drug: Haloperidole Drug: Quetiapin Drug: Escitalopram Drug: Citalopram Drug: Sertralin

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 in use, despite its lack of clinical evidence.

We will discontinue antipsychotics in one group of 12 patients and antidepressants in one group of 12 patients. 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 an open labelled study with no control group. Based on the results of this study, we will design a 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: NCT00433121

Locations

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

Sponsors and Collaborators

Sykehuset Innlandet HF

Demensforbundet, Norway

Investigators

Study Chair:

Knut Engedal, Ph D

The Norwegian Centre for Dementia Research (NCDR), Norway

More Information

No publications provided

Study ID Numbers:	101
Study First Received:	February 1, 2007
Last Updated:	August 23, 2007
ClinicalTrials.gov Identifier:	NCT00433121 History of Changes
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:

Antidepressive Agents
Neuroleptica
Dementia
Discontinuation study
Behavioural- and Psychological Symptoms in Dementia

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Olanzapine
Antiemetics
Brain Diseases
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Dementia
Antidepressive Agents, Second-Generation
Antidepressive Agents
Tranquilizing Agents

Nervous System Diseases
Gastrointestinal Agents
Risperidone
Central Nervous System Diseases
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
Serotonin Agents
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009