Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00433121

Enrollment

Registered

2007-02-09

Start date

2006-09-30

Completion date

2007-08-31

Last updated

2007-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

Antidepressive Agents, Neuroleptica, Dementia, Discontinuation study, Behavioural- and Psychological Symptoms in Dementia

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.

Interventions

DRUGOlanzapine

DRUGHaloperidole

DRUGQuetiapin

DRUGEscitalopram

DRUGCitalopram

DRUGSertralin

DRUGRisperidone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Changes in Quality of Live - Alzheimer Disease	24 weeks
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

Secondary

Measure	Time frame
Changes in Lawton's PADL	24 weeks
Oxazepam given p.n.	24 weeks
Drop outs	24 weeks
Changes in Severe Impairment Battery	24 weeks

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026