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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

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.

Condition or disease Intervention/treatment Phase
Delirium Drug: Risperidone and Zotepine for delirium Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risperidone and Zotepine in the Treatment of Delirium
Actual Study Start Date : January 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: 1
zotepine , start from 50mg/day then titrate according to individual case
Drug: Risperidone and Zotepine for delirium
try risperidone or zotepine in the treatment of delirium
Other Name: risperidone( Risperdal), zotepine( Lodopine)

Active Comparator: 2
Risperidone, start from 1mg/day
Drug: Risperidone and Zotepine for delirium
try risperidone or zotepine in the treatment of delirium
Other Name: risperidone( Risperdal), zotepine( Lodopine)

Primary Outcome Measures :
  1. Delirium rating scale [ Time Frame: 1/2 day, then every 24 hours ]

Secondary Outcome Measures :
  1. MMSE, CGI, side effect profile, HRV [ Time Frame: 12 hours, then every 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00622011

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Changhua Christian Hospital
Changhua, Taiwan, 500
Sponsors and Collaborators
Changhua Christian Hospital
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Principal Investigator: Cheng-Chen Chang, M.D. Changhua Christian Hospital
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Responsible Party: Changhua Christian Hospital Identifier: NCT00622011    
Other Study ID Numbers: CCH070906
CCH grant
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents