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

Sponsor:

Information provided by:

Changhua Christian Hospital

ClinicalTrials.gov Identifier:

NCT00622011

First received: January 31, 2008

Last updated: February 11, 2008

Last verified: January 2008

History of Changes

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:

MedlinePlus related topics: Delirium

Drug Information available for: Zolpidem Zolpidem tartrate Risperidone

U.S. FDA Resources

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
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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
Study First Received:	January 31, 2008
Last Updated:	February 11, 2008
Health Authority:	Taiwan: Institutional Review Board

Additional relevant MeSH terms:


Delirium Confusion Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Risperidone Zolpidem Antipsychotic Agents Central Nervous System Agents Central Nervous System Depressants Dopamine Agents	Dopamine Antagonists GABA Agents GABA Agonists GABA-A Receptor Agonists Hypnotics and Sedatives Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Serotonin Antagonists Therapeutic Uses Tranquilizing Agents

ClinicalTrials.gov processed this record on February 27, 2015

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