Dementia Antipsychotics And Antidepressants Discontinuation Study

Phase 4

Completed

• Conditions: Dementia
• Interventions: Drug: Risperidone; Drug: Escitalopram; Drug: Citalopram; Drug: Sertraline; Drug: Paroxetine

• Registration Number: NCT00594269
• Lead Sponsor: Sykehuset Innlandet HF

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.

Study Timeline

• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-03
• Study First Posted: 2008-01-15
• Study Start: 2008-08
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

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Exclusion Criteria

• Dementia of other origin
• Psychiatric disease
• Life expectancy less than 3 months
• Acute infection last 10 days
• Unstable Diabetes Mellitus
• Terminal disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Sertraline	Discontinuation of antipsychotic or antidepressants
A	Paroxetine	Discontinuation of antipsychotic or antidepressants
A	Risperidone	Discontinuation of antipsychotic or antidepressants
A	Escitalopram	Discontinuation of antipsychotic or antidepressants
A	Citalopram	Discontinuation of antipsychotic or antidepressants

Primary Outcome Measures

Name	Time	Method
Changes in Neuropsychiatric Inventory	24 weeks
Changes in Cornell's Depression Scale	24 weeks
Changes in UPDRS subscale	24 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in Severe Impairment Battery	24 weeks
Changes in Lawton's PADL	24 weeks
Oxazepam given p.n.	24 weeks
Number of falls	24 weeks
Changes in Body Weight	24 weeks
Quality of Life - Alzheimer disease	24 weeks
Clinical Dementia Rating	24 weeks

Trial Locations

Locations (8)

Sykehuset Innlandet HF; 🇳🇴 Reinsvoll, Oppland, Norway

Diakonihjemmets Hospital; 🇳🇴 Oslo, Norway

Ullevaal University Hospital; 🇳🇴 Oslo, Norway

Sykehuset Innlandet HF - Sanderud; 🇳🇴 Ottestad, Oppland, Norway

Eikertun Nursing Home; 🇳🇴 Hokksund, Norway

University of Bergen, Løvaasen Nursing Home; 🇳🇴 Bergen, Norway

The Nordmøre and Romsdal Hospital Trust; 🇳🇴 Molde, Norway

Telemark Hospital; 🇳🇴 Skien, Norway