Dementia Antipsychotics And Antidepressants Discontinuation Study

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

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

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.

Intervention(s) in this Clinical Trial

• Drug: Risperidone
  • Discontinuation
• Drug: Escitalopram
  • Discontinuation
• Drug: Citalopram
  • Discontinuation
• Drug: Sertraline
  • Discontinuation
• Drug: Paroxetine
  • Discontinuation

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A
  • Discontinuation of antipsychotic or antidepressants

Primary Measures

• Changes in Neuropsychiatric Inventory
  • Time Frame: 24 weeks
    Safety Issue?: No
• Changes in Cornell's Depression Scale
  • Time Frame: 24 weeks
    Safety Issue?: No
• Changes in UPDRS subscale
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• Changes in Severe Impairment Battery
  • Time Frame: 24 weeks
    Safety Issue?: No
• Changes in Lawton's PADL
  • Time Frame: 24 weeks
    Safety Issue?: No
• Oxazepam given p.n.
  • Time Frame: 24 weeks
    Safety Issue?: No
• Number of falls
  • Time Frame: 24 weeks
    Safety Issue?: No
• Changes in Body Weight
  • Time Frame: 24 weeks
    Safety Issue?: No
• Quality of Life - Alzheimer disease
  • Time Frame: 24 weeks
    Safety Issue?: No
• Clinical Dementia Rating
  • Time Frame: 24 weeks
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sykehuset Innlandet HF Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00594269

Study ID Number: F06001

ClinicalTrials.gov Identifier: NCT00594269

Health Authority: Norway: Norwegian Medicines Agency