Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD - Tabular View

Tracking Information

First Received Date ^ICMJE

February 1, 2007

Last Updated Date

August 23, 2007

Start Date ^ICMJE

September 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Changes in Neuropsychiatric Inventory
Changes in weight
Changes in Cornell's Depression Scale
Changes in UPDRS subscale
Changes in Quality of Life - Alzheimer Disease

Change History

Complete list of historical versions of study NCT00433121 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 ]
Drop outs [ Time Frame: 24 weeks ]

Original Secondary Outcome Measures ^ICMJE

Changes in Severe Impairment Battery
Changes in Lawton's PADL
Oxazepam given p.n.
Drop outs

Descriptive Information

Brief Title ^ICMJE

Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

Official Title ^ICMJE

Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study.

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 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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Dementia

Intervention ^ICMJE

Drug: Risperidone
Drug: Olanzapine
Drug: Haloperidole
Drug: Quetiapin
Drug: Escitalopram
Drug: Citalopram
Drug: Sertralin

Study Arms / Comparison Groups

Experimental: Discontinuation of neuroleptic or anti depressants

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

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

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 information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00433121

Responsible Party

Study ID Numbers ^ICMJE

101

Study Sponsor ^ICMJE

Sykehuset Innlandet HF

Collaborators ^ICMJE

Demensforbundet, Norway

Investigators ^ICMJE

Study Chair:

Knut Engedal, Ph D

The Norwegian Centre for Dementia Research (NCDR), Norway

Information Provided By

Sykehuset Innlandet HF

Verification Date

August 2007

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