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Completed

NCT Number: NCT00594269

Dementia Antipsychotics And Antidepressants Discontinuation 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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sykehuset Innlandet HF - Sanderud, Ottestad, Oppland, Norway

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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 used as treatment, despite its lack of clinical evidence.

We will discontinue risperidone in one group of 30 patients and compere them to 30 controls and we will discontinue antidepressants in a group of 76 patients and compere them to 76 controls. 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 a double blind 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

Discontinuation

Other names: ATC code N05AX 08

Escitalopram

Drug

Discontinuation

Other names: ATC code N06AB 10

Citalopram

Drug

Discontinuation

Other names: ATC code N06AB 04

Sertraline

Drug

Discontinuation

Other names: ATC code N06AB 06

paroxetine

Drug

Discontinuation

Other names: ATC code N06AB 05

Primary outcomes

  1. Changes in Neuropsychiatric Inventory

    Time frame: 24 weeks

  2. Changes in Cornell's Depression Scale

    Time frame: 24 weeks

  3. Changes in UPDRS subscale

    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. Number of falls

    Time frame: 24 weeks

  5. Changes in Body Weight

    Time frame: 24 weeks

  6. Quality of Life - Alzheimer disease

    Time frame: 24 weeks

  7. Clinical Dementia Rating

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Sykehuset Innlandet HF

Other

Collaborators

  • Alesund Hospital
  • Bjørgene Omsorgssenter, Haugesund
  • Diakonhjemmet Hospital
  • Eikertun Nursing Home
  • Innlandet Hospital Trust, Reinsvoll
  • Innlandet Hospital Trust, Sanderud
  • Kløveråsen, Bodø
  • Kroken Nursing Home, Tromsø
  • Songdalstunet Nursing Home
  • Sykehuset Buskerud HF
  • Sykehuset Telemark
  • The Nordmøre and Romsdal Hospital Trust
  • Ullevaal University Hospital
  • University of Bergen

Registry information

Official study title

Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.

Acronym: DESEP

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 15, 2008
Registry last updated
Feb 23, 2011

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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