Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

Sykehuset Innlandet HF

Status and phase: Completed; Phase 4

Conditions: Dementia

Treatments: Drug: Olanzapine; Drug: Escitalopram; Drug: Haloperidole; Drug: Citalopram; Drug: Quetiapin; Drug: Sertralin; Drug: Risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT00433121

101

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

A

Experimental group

Description:

Discontinuation of neuroleptic or anti depressants

Treatment:

Drug: Haloperidole

Drug: Escitalopram

Drug: Quetiapin

Drug: Citalopram

Drug: Olanzapine

Drug: Sertralin

Drug: Risperidone