NCT00594269

Dementia Antipsychotics And Antidepressants Discontinuation Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Sykehuset Innlandet HF · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia

Interventions

Type	Name	Description
DRUG	Risperidone	Discontinuation
DRUG	Escitalopram	Discontinuation
DRUG	Citalopram	Discontinuation
DRUG	Sertraline	Discontinuation
DRUG	Paroxetine	Discontinuation

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-01-15
• Last updated: 2011-02-23

Locations

8 sites across 1 country: Norway