Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

Phase 4

Completed

• Conditions: Dementia
• Interventions: Drug: Risperidone; Drug: Olanzapine; Drug: Haloperidole; Drug: Quetiapin; Drug: Escitalopram; Drug: Citalopram; Drug: Sertralin

• Registration Number: NCT00433121
• 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 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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-02-01
• Study First Submitted QC: 2007-02-08
• Study First Posted: 2007-02-09
• Status Verified: 2007-08
• Study Completion: 2007-08
• Last Update Submitted: 2007-08-23
• Last Update Posted: 2007-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Haloperidole	Discontinuation of neuroleptic or anti depressants
A	Quetiapin	Discontinuation of neuroleptic or anti depressants
A	Sertralin	Discontinuation of neuroleptic or anti depressants
A	Olanzapine	Discontinuation of neuroleptic or anti depressants
A	Risperidone	Discontinuation of neuroleptic or anti depressants
A	Escitalopram	Discontinuation of neuroleptic or anti depressants
A	Citalopram	Discontinuation of neuroleptic or anti depressants

Primary Outcome Measures

Name	Time	Method
Changes in Neuropsychiatric Inventory	24 weeks
Changes in weight	24 weeks
Changes in Cornell's Depression Scale	24 weeks
Changes in UPDRS subscale	24 weeks
Changes in "Quality of Live - Alzheimer Disease"	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
Drop outs	24 weeks

Trial Locations

Locations (1)

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