Risperidone and Zotepine in the Treatment of Delirium
Information source: Changhua Christian Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Delirium
Intervention: Risperidone and Zolpidem for delirium (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Changhua Christian Hospital Official(s) and/or principal investigator(s): Cheng-Chen Chang, M.D., Principal Investigator, Affiliation: Changhua Christian Hospital
Overall contact: Cheng-Chen Chang, M.D., Phone: 886-4-7238595, Ext: 7172, Email: 55810@cch.org.tw
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 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.
Clinical Details
Official title: Risperidone and Zotepine in the Treatment of Delirium
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Delirium rating scale
Secondary outcome: MMSE, CGI, side effect profile, HRV
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 drug given. The initial starting dose of each drug is
1mg(risperidone) or 50 mg(zotepine) once a day. The dosage was increased depending on the
status of delirium during the first 7 days and will be adjusted until patients are maximally
stabilized or until intolerable adverse events necessitated cessation. Risperidone or
zotepine will be tapered off in 10 days when patients are considered stable. No concomitant
psychotropic medications will be used during the study except for lorazepam, which are given
for severe agitation or insomnia . Patients are assessed by another rater blinded to active
drug at the time of enrollment, the subsequent 12, 24,and then assessed daily until
discharge. The study period is estimated to be around 12 months upon the designed number of
subjects are reached.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Cheng-Chen Chang, M.D., Phone: 886-4-7238595, Ext: 7172, Email: 55810@cch.org.tw
Changhua Christian Hospital, Changhua 500, Taiwan; Recruiting Cheng-Chen Chang, M.D., Phone: 886-4-7238595, Ext: 7172, Email: 55810@cch.org.tw
Additional Information
Related publications: 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.
Starting date: January 2008
Last updated: February 11, 2008
|