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OpenTrials
Completed

NCT Number: NCT00433121

Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sykehuset Innlandet HF - Sanderud

Ottestad, Oppland, 2312, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risperidone

Drug

Olanzapine

Drug

haloperidole

Drug

Quetiapin

Drug

Escitalopram

Drug

Citalopram

Drug

Sertralin

Drug

Primary outcomes

  1. Changes in Neuropsychiatric Inventory

    Time frame: 24 weeks

  2. Changes in weight

    Time frame: 24 weeks

  3. Changes in Cornell's Depression Scale

    Time frame: 24 weeks

  4. Changes in UPDRS subscale

    Time frame: 24 weeks

  5. Changes in "Quality of Live - Alzheimer Disease"

    Time frame: 24 weeks

Secondary outcomes

  1. Changes in Severe Impairment Battery

    Time frame: 24 weeks

  2. Changes in Lawton's PADL

    Time frame: 24 weeks

  3. Oxazepam given p.n.

    Time frame: 24 weeks

  4. Drop outs

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Sykehuset Innlandet HF

Other

Collaborators

  • Demensforbundet, Norway

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Feb 9, 2007
Registry last updated
Aug 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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