- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01303367
Medication Management and Care of Demented Patients With Behavioral and Psychological Symptoms of Dementia in Taiwan: A Retrospective Pilot Study
Přehled studie
Postavení
Podmínky
Detailní popis
Cumulative observations indicate that demented patients withdrawn antipsychotics may not exacerbate BPSD.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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Taipei, Tchaj-wan
- Taipei Medical University - WanFang Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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antipsychotic agents
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non-antipsychotic agents
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Winston Wu-Dien Shen, Taipei Medical University WanFang Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 99076
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