Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

August 23, 2007 updated by: Sykehuset Innlandet HF

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Discontinuation of neuroleptic or anti depressants
Drug: Olanzapine
Drug: Escitalopram
Drug: Risperidone
Drug: Citalopram
Drug: Haloperidole
Drug: Quetiapin
Drug: Sertralin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Neuropsychiatric Inventory
Time Frame: 24 weeks
24 weeks
Changes in weight
Time Frame: 24 weeks
24 weeks
Changes in Cornell's Depression Scale
Time Frame: 24 weeks
24 weeks
Changes in UPDRS subscale
Time Frame: 24 weeks
24 weeks
Changes in "Quality of Live - Alzheimer Disease"
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in Severe Impairment Battery
Time Frame: 24 weeks
24 weeks
Changes in Lawton's PADL
Time Frame: 24 weeks
24 weeks
Oxazepam given p.n.
Time Frame: 24 weeks
24 weeks
Drop outs
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Innlandet HF

Collaborators

Demensforbundet, Norway

Investigators

  • Study Chair: Knut Engedal, Ph D, The Norwegian Centre for Dementia Research (NCDR), Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 8, 2007

First Posted (Estimate)

February 9, 2007

Study Record Updates

Last Update Posted (Estimate)

August 24, 2007

Last Update Submitted That Met QC Criteria

August 23, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101 (Other Identifier: Hamilton Integrated Research Ethics Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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