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Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

NCT ID: NCT00433121

Last Updated: 2007-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-08-31

Brief Summary

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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

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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.

Conditions

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Dementia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Discontinuation of neuroleptic or anti depressants

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

Olanzapine

Intervention Type DRUG

Haloperidole

Intervention Type DRUG

Quetiapin

Intervention Type DRUG

Escitalopram

Intervention Type DRUG

Citalopram

Intervention Type DRUG

Sertralin

Intervention Type DRUG

Interventions

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Risperidone

Intervention Type DRUG

Olanzapine

Intervention Type DRUG

Haloperidole

Intervention Type DRUG

Quetiapin

Intervention Type DRUG

Escitalopram

Intervention Type DRUG

Citalopram

Intervention Type DRUG

Sertralin

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Demensforbundet, Norway

UNKNOWN

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role lead

Principal Investigators

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Knut Engedal, Ph D

Role: STUDY_CHAIR

The Norwegian Centre for Dementia Research (NCDR), Norway

Locations

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Sykehuset Innlandet HF - Sanderud

Ottestad, Oppland, Norway

Site Status

Countries

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Norway

Other Identifiers

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101

Identifier Type: -

Identifier Source: org_study_id