Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

This study has been completed.
Sponsor:
Collaborator:
Demensforbundet, Norway
Information provided by:
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00433121
First received: February 1, 2007
Last updated: August 23, 2007
Last verified: August 2007

February 1, 2007
August 23, 2007
September 2006
Not Provided
  • Changes in Neuropsychiatric Inventory [ Time Frame: 24 weeks ]
  • Changes in weight [ Time Frame: 24 weeks ]
  • Changes in Cornell's Depression Scale [ Time Frame: 24 weeks ]
  • Changes in UPDRS subscale [ Time Frame: 24 weeks ]
  • Changes in "Quality of Live - Alzheimer Disease" [ Time Frame: 24 weeks ]
  • Changes in Neuropsychiatric Inventory
  • Changes in weight
  • Changes in Cornell's Depression Scale
  • Changes in UPDRS subscale
  • Changes in Quality of Life - Alzheimer Disease
Complete list of historical versions of study NCT00433121 on ClinicalTrials.gov Archive Site
  • Changes in Severe Impairment Battery [ Time Frame: 24 weeks ]
  • Changes in Lawton's PADL [ Time Frame: 24 weeks ]
  • Oxazepam given p.n. [ Time Frame: 24 weeks ]
  • Drop outs [ Time Frame: 24 weeks ]
  • Changes in Severe Impairment Battery
  • Changes in Lawton's PADL
  • Oxazepam given p.n.
  • Drop outs
Not Provided
Not Provided
 
Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD
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).

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dementia
  • Drug: Risperidone
  • Drug: Olanzapine
  • Drug: Haloperidole
  • Drug: Quetiapin
  • Drug: Escitalopram
  • Drug: Citalopram
  • Drug: Sertralin
Experimental: A
Discontinuation of neuroleptic or anti depressants
Interventions:
  • Drug: Risperidone
  • Drug: Olanzapine
  • Drug: Haloperidole
  • Drug: Quetiapin
  • Drug: Escitalopram
  • Drug: Citalopram
  • Drug: Sertralin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2007
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00433121
101
No
Not Provided
Sykehuset Innlandet HF
Demensforbundet, Norway
Study Chair: Knut Engedal, Ph D The Norwegian Centre for Dementia Research (NCDR), Norway
Sykehuset Innlandet HF
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP