Status:
TERMINATED
Risperidone and Zotepine in the Treatment of Delirium
Lead Sponsor:
Changhua Christian Hospital
Conditions:
Delirium
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Qualified inpatients will be enrolled and randomly given a flexible-dose regimen of Risperidone or Zotepine. Autonomic dysfunction is checked using analysis of heart rate variability before any active...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00622011
Start Date
January 1 2008
End Date
March 1 2009
Last Update
February 17 2020
Active Locations (1)
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1
Changhua Christian Hospital
Changhua, Taiwan, 500