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
Recruitment status was Recruiting
Sponsor:
Changhua Christian Hospital
Information provided by:
Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT00622011
First received: January 31, 2008
Last updated: February 11, 2008
Last verified: January 2008
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Purpose
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 |
|---|---|---|
|
Delirium |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00622011
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622011
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
Publications:
| 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 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 |
ClinicalTrials.gov processed this record on September 26, 2016