Clinical trial NCT00594269: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dementia
Keywords: Antidepressants
Antipsychotics
Dementia
Discontinuation study
Behavioural- and Psychological Symptoms in Dementia
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Ullevaal University Hospital
name: Eikertun Nursing Home
name: University of Bergen
name: Innlandet Hospital Trust, Sanderud
name: Innlandet Hospital Trust, Reinsvoll
name: Diakonhjemmet Hospital
name: Sykehuset Telemark
name: The Nordmøre and Romsdal Hospital Trust
name: Songdalstunet Nursing Home
name: Sykehuset Buskerud HF
name: Kroken Nursing Home, Tromsø
name: Kløveråsen, Bodø
name: Bjørgene Omsorgssenter, Haugesund
name: Alesund Hospital
First posted: 2008-01-15
Enrollment: 149
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Neuropsychiatric Inventory
timeFrame: 24 weeks
measure: Changes in Cornell's Depression Scale
timeFrame: 24 weeks
measure: Changes in UPDRS subscale
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes in Severe Impairment Battery
timeFrame: 24 weeks
measure: Changes in Lawton's PADL
timeFrame: 24 weeks
measure: Oxazepam given p.n.
timeFrame: 24 weeks
measure: Number of falls
timeFrame: 24 weeks
measure: Changes in Body Weight
timeFrame: 24 weeks
measure: Quality of Life - Alzheimer disease
timeFrame: 24 weeks
measure: Clinical Dementia Rating
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Ottestad
country: Norway
facility: Sykehuset Innlandet HF - Sanderud
state: Oppland
city: Reinsvoll
country: Norway
facility: Sykehuset Innlandet HF
state: Oppland
city: Bergen
country: Norway
facility: University of Bergen, Løvaasen Nursing Home
city: Hokksund
country: Norway
facility: Eikertun Nursing Home
city: Molde
country: Norway
facility: The Nordmøre and Romsdal Hospital Trust
city: Oslo
country: Norway
facility: Diakonihjemmets Hospital
city: Oslo
country: Norway
facility: Ullevaal University Hospital
city: Skien
country: Norway
facility: Telemark Hospital
Study officials:
affiliation: The Norwegian Centre for Dementia Research (NCDR), Norway
name: Knut Engedal, Ph D
role: STUDY_CHAIR
affiliation: Innlandet Hospital Trust, Sanderud
name: Sverre Bergh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergh S, Selbaek G, Engedal K. Discontinuation of antidepressants in people with dementia and neuropsychiatric symptoms (DESEP study): double blind, randomised, parallel group, placebo controlled trial. BMJ. 2012 Mar 9;344:e1566. doi: 10.1136/bmj.e1566.