Risperidone and Zotepine in the Treatment of Delirium
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ClinicalTrials.gov Identifier: NCT00622011 |
Recruitment Status :
Terminated
(inadequate participant)
First Posted : February 22, 2008
Last Update Posted : February 17, 2020
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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 |
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 |

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) |
- Delirium rating scale [ Time Frame: 1/2 day, then every 24 hours ]
- MMSE, CGI, side effect profile, HRV [ Time Frame: 12 hours, then every 24 hours ]

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00622011
Taiwan | |
Changhua Christian Hospital | |
Changhua, Taiwan, 500 |
Principal Investigator: | Cheng-Chen Chang, M.D. | Changhua Christian Hospital |
Responsible Party: | Changhua Christian Hospital |
ClinicalTrials.gov 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 |
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Neurocognitive Disorders Mental Disorders Risperidone Zotepine 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 |