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Delirium | Risperidone and Zotepine in the Treatment of Delirium

Delirium research study

What is the primary objective of this study?

Delirium is an organic psychiatric syndrome characterized by fluctuating consciousness and impairment in perception, cognition and behavior. In hospitalized elderly, the prevalence of delirium ranges from 10% to 40%. If untreated, delirium is associated with significant morbidity and mortality. Treatment of delirium consists of identifying and managing underlying medical abnormalities and the associated psychiatric symptoms. Conventional antipsychotics have been the mainstay of treatment of agitation and psychosis associated with delirium; but their use is limited in terms of EPS side effects. Second-generation antipsychotic agents have been reported to have a lower incidence of extrapyramidal side effects and tardive dyskinesia which has resulted in their increased use in the treatment of delirious patients. However, there is still no consensus regarding standard pharmacologic treatment of this syndrome that takes use of second-generation antipsychotic agents into account. Risperidone and zotepine have a lower incidence of EPS and are effective in treating disturbing psychotic behaviors. We hope to compare the efficacy and safety of risperidone and zotepine in the treatment of delirium and the correlation between the severity of delirium with autonomic dysfunction.

Who is eligible to participate?

Inclusion Criteria: - Patients may be included in the study if they meet all of the following criteria:DSM-IV-TR delirium (293.0 delirium due to general medical condition, 290.3 dementia with delirium 290.41, arteriosclerotic dementia with delirium 780.09delirium NOS. 292.8 substance-induced delirium( excluding alcohol and BZD) - Age 18 to 85 year-old inpatients; either sex - Patients are able to take Risperidone or Zotepine orally Exclusion Criteria: - Alcohol-induced delirium; delirium caused by seizures; Sedative, hypnotic or anxiolytic withdrawal delirium - Patients with schizophrenia or bipolar disorder or being treated with antipsychotics - Patients are mandatory to take parenteral treatments - Patients are known to be allergic to Risperidone or Zotepine - Women with pregnancy or during lactation.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Delirium

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Risperidone and Zolpidem for deliriumtry risperidone or zolpidem in the treatment of delirium

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1zolpidem , start from 50mg/day then titrate according to individual case

2Risperidone, start from 1mg/day

Study Status

Unknown status

Start Date: January 2008

Completed Date: January 2009

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Delirium rating scale

Secondary Outcome: MMSE, CGI, side effect profile, HRV

Study sponsors, principal investigator, and references

Principal Investigator: Cheng-Chen Chang, M.D.

Lead Sponsor: Changhua Christian Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00622011

Boettger S, Breitbart W. Atypical antipsychotics in the management of delirium: a review of the empirical literature. Palliat Support Care. 2005 Sep;3(3):227-37. Review.

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