Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Risperidone and Zotepine in the Treatment of Delirium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00622011
Recruitment Status : Terminated (inadequate participant)
First Posted : February 22, 2008
Last Update Posted : February 17, 2020
Information provided by (Responsible Party):
Changhua Christian Hospital

Tracking Information
First Submitted Date  ICMJE January 31, 2008
First Posted Date  ICMJE February 22, 2008
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE January 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
Delirium rating scale [ Time Frame: 1/2 day, then every 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
MMSE, CGI, side effect profile, HRV [ Time Frame: 12 hours, then every 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Risperidone and Zotepine in the Treatment of Delirium
Official Title  ICMJE Risperidone and Zotepine in the Treatment of Delirium
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 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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Delirium
Intervention  ICMJE Drug: Risperidone and Zotepine for delirium
try risperidone or zotepine in the treatment of delirium
Other Name: risperidone( Risperdal), zotepine( Lodopine)
Study Arms  ICMJE
  • Experimental: 1
    zotepine , start from 50mg/day then titrate according to individual case
    Intervention: Drug: Risperidone and Zotepine for delirium
  • Active Comparator: 2
    Risperidone, start from 1mg/day
    Intervention: Drug: Risperidone and Zotepine for delirium
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 13, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2008)
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00622011
Other Study ID Numbers  ICMJE CCH070906
CCH grant
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Changhua Christian Hospital
Study Sponsor  ICMJE Changhua Christian Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cheng-Chen Chang, M.D. Changhua Christian Hospital
PRS Account Changhua Christian Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP