Dementia Antipsychotics And Antidepressants Discontinuation Study (DESEP)

Sykehuset Innlandet HF

Status and phase: Completed; Phase 4

Conditions: Dementia

Treatments: Drug: Escitalopram; Drug: Citalopram; Drug: Sertraline; Drug: Risperidone; Drug: Paroxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT00594269

F06001

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 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.

Enrollment: 149 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: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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149 participants in 1 patient group, including a placebo group

A

Placebo Comparator group

Description:

Discontinuation of antipsychotic or antidepressants

Treatment:

Drug: Paroxetine

Drug: Sertraline

Drug: Risperidone

Drug: Citalopram

Drug: Escitalopram