Medication Management and Care of Demented Patients With Behavioral and Psychological Symptoms of Dementia in Taiwan: A Retrospective Pilot Study
Visão geral do estudo
Status
Condições
Descrição detalhada
Cumulative observations indicate that demented patients withdrawn antipsychotics may not exacerbate BPSD. The DART-AD study shows that both demented patients with/without antipsychotics for six months have no significant difference in cognitive symptoms and BPSD (Ballard et al., 2008). Moreover, the results of a long-term follow-up DART-AD study demonstrate that the survival rate of demented patients with antipsychotics is lower than those without antipsychotics at 24th month (with group vs. without group = 40% vs. 71%) and 36th month (with group vs. without group = 30% vs. 59%), respectively (Ballard et al., 2009). Recently, several studies indicate that antidepressants such as citalopram and milnacipran might be a new medication management for demented patients with BPSD (Pollock et al., 2007).
The present study is designed as a retrospective open-label pilot study. The initial research goal of this study is to determine the prevalence of psychotropic agents in demented patients in Taiwan National Health Insurance Research Database (NHIRD) (2005 v.s. 2008) and prescription rates of psychotropic agents in demented patients in Taipei Medical University-Teaching Hospitals (from 2002 to 2010). The psychotropic agents are defined as antipsychotic, antidepressant, sedative-hypnotic, anticonvulsant agents. Moreover, the second objective of this study is to investigate the risk of cardiovascular and aspiration pneumonia. Finally, the results of this study could be used to create the best and practical protocol of treatment for BPSD in demented patients of Taiwan to improve their drug safety and quality of life.
Currently, there is no treatment for BPSD, and pharmacists should recommend physicians to decrease the off-label use of antipsychotics in demented patients with BPSD. The main reason is due to the fact that off-label use of antipsychotics increases significantly the mortality rate of demented patients. The therapeutic management of BPSD should be based on the evidence-based medicine and patient safety.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
Taipei, Taiwan
- Taipei Medical University - WanFang Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- This study is planning to study patients with dementia (ICD-code: 290.XX), Alzheimer's disease (ICD-code: 331.0), and/or other organic psychotic conditions (chronic) (ICD-code: 294.XX), including delirium, delusion, depressive features, and/or in conditions classified elsewhere with behavior disturbance.
- This study is to include demented patients with mild to moderate cognitive impairment (mini-mental state examination [MMSE] = 10-24/ Clinical Dementia Rating [CDR] = 0.5-2).
Exclusion Criteria:
- The present proposal excludes patients with a primary history of schizophrenic disorder (ICD-code: 295XX) and bipolar disorder (296XX).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
antipsychotic agents
|
|
non-antipsychotic agents
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Winston Wu-Dien Shen, Taipei Medical University WanFang Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 99076
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .