Risperidone and Zotepine in the Treatment of Delirium

Study Description

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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 Zolpidem 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Risperidone and Zotepine in the Treatment of Delirium
Study Start Date :	January 2008
Estimated Primary Completion Date :	December 2008
Estimated Study Completion Date :	January 2009

Arms and Interventions

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Arm	Intervention/treatment
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)

Outcome Measures

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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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

Taiwan
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

Investigators

Principal Investigator:	Cheng-Chen Chang, M.D.	Changhua Christian Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Responsible Party:	Cheng-Chen Chang, Changhua Christian Hospital, Psy. Dept.
ClinicalTrials.gov Identifier:	NCT00622011 History of Changes
Other Study ID Numbers:	CCH070906; CCH grant
First Posted:	February 22, 2008
Last Update Posted:	February 22, 2008
Last Verified:	January 2008

Additional relevant MeSH terms:

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Risperidone; Zotepine; Zolpidem; 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; Hypnotics and Sedatives; GABA-A Receptor Agonists; GABA Agonists; GABA Agents