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Sponsored by: |
Changhua Christian Hospital |
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Information provided by: | Changhua Christian Hospital |
ClinicalTrials.gov Identifier: | NCT00622011 |
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 |
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Delirium |
Drug: Risperidone and Zolpidem for delirium |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Risperidone and Zotepine in the Treatment of Delirium |
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 |
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1: Experimental
zolpidem , start from 50mg/day then titrate according to individual case
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Drug: Risperidone and Zolpidem for delirium
try risperidone or zolpidem in the treatment of delirium
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2: Active Comparator
Risperidone, start from 1mg/day
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Drug: Risperidone and Zolpidem for delirium
try risperidone or zolpidem in the treatment of delirium
|
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:
Exclusion Criteria:
Contact: Cheng-Chen Chang, M.D. | 886-4-7238595 ext 7172 | 55810@cch.org.tw |
Taiwan | |
Changhua Christian Hospital | Recruiting |
Changhua, Taiwan, 500 | |
Contact: Cheng-Chen Chang, M.D. 886-4-7238595 ext 7172 55810@cch.org.tw |
Principal Investigator: | Cheng-Chen Chang, M.D. | Changhua Christian Hospital |
Responsible Party: | Changhua Christian Hospital, Psy. Dept. ( Cheng-Chen Chang ) |
Study ID Numbers: | CCH070906, CCH grant |
Study First Received: | January 31, 2008 |
Last Updated: | February 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00622011 |
Health Authority: | Taiwan: Institutional Review Board |
Zolpidem Zotepine Risperidone Confusion Cognition Disorders Serotonin Signs and Symptoms |
Dopamine Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurologic Manifestations Dementia Neurobehavioral Manifestations Delirium |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents |
Pharmacologic Actions Serotonin Antagonists Serotonin Agents GABA Agonists Therapeutic Uses Hypnotics and Sedatives GABA Agents Dopamine Agents Central Nervous System Agents |