Dementia Antipsychotics And Antidepressants Discontinuation Study

Dementia Clinical Trial

— DESEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594269
• Other study ID #: F06001
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2008
• Last updated: February 22, 2011
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

Intervention

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

Locations

Country	Name	City	State
Norway	University of Bergen, Løvaasen Nursing Home	Bergen
Norway	Eikertun Nursing Home	Hokksund
Norway	The Nordmøre and Romsdal Hospital Trust	Molde
Norway	Diakonihjemmets Hospital	Oslo
Norway	Ullevaal University Hospital	Oslo
Norway	Sykehuset Innlandet HF - Sanderud	Ottestad	Oppland
Norway	Sykehuset Innlandet HF	Reinsvoll	Oppland
Norway	Telemark Hospital	Skien

Sponsors (15)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF	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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Neuropsychiatric Inventory		24 weeks	No
Primary	Changes in Cornell's Depression Scale		24 weeks	No
Primary	Changes in UPDRS subscale		24 weeks	No
Secondary	Changes in Severe Impairment Battery		24 weeks	No
Secondary	Changes in Lawton's PADL		24 weeks	No
Secondary	Oxazepam given p.n.		24 weeks	No
Secondary	Number of falls		24 weeks	No
Secondary	Changes in Body Weight		24 weeks	No
Secondary	Quality of Life - Alzheimer disease		24 weeks	No
Secondary	Clinical Dementia Rating		24 weeks	No