Risperidone and Zotepine in the Treatment of Delirium

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Changhua Christian Hospital.
Recruitment status was  Recruiting
Information provided by:
Changhua Christian Hospital
ClinicalTrials.gov Identifier:
First received: January 31, 2008
Last updated: February 11, 2008
Last verified: January 2008

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.

Condition Intervention Phase
Drug: Risperidone and Zolpidem for delirium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Risperidone and Zotepine in the Treatment of Delirium

Resource links provided by NLM:

Further study details as provided by Changhua Christian Hospital:

Primary Outcome Measures:
  • Delirium rating scale [ Time Frame: 1/2 day, then every 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MMSE, CGI, side effect profile, HRV [ Time Frame: 12 hours, then every 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
zolpidem , start from 50mg/day then titrate according to individual case
Drug: Risperidone and Zolpidem for delirium
try risperidone or zolpidem in the treatment of delirium
Other Name: risperidone( Risperdal), zolpidem( Lodopine)
Active Comparator: 2
Risperidone, start from 1mg/day
Drug: Risperidone and Zolpidem for delirium
try risperidone or zolpidem in the treatment of delirium
Other Name: risperidone( Risperdal), zolpidem( Lodopine)

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.

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00622011

Contact: Cheng-Chen Chang, M.D. 886-4-7238595 ext 7172 55810@cch.org.tw

Changhua Christian Hospital Recruiting
Changhua, Taiwan, 500
Contact: Cheng-Chen Chang, M.D.    886-4-7238595 ext 7172    55810@cch.org.tw   
Sponsors and Collaborators
Changhua Christian Hospital
Principal Investigator: Cheng-Chen Chang, M.D. Changhua Christian Hospital
  More Information

Responsible Party: Cheng-Chen Chang, Changhua Christian Hospital, Psy. Dept.
ClinicalTrials.gov Identifier: NCT00622011     History of Changes
Other Study ID Numbers: CCH070906  CCH grant 
Study First Received: January 31, 2008
Last Updated: February 11, 2008
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
GABA Agents
GABA Agonists
GABA-A Receptor Agonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on February 04, 2016