Risperidone and Zotepine in the Treatment of Delirium

NCT00622011 | Terminated Phase 4

• 2 other identifiers: CCH070906CCH grant
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Delirium rating scale

  1/2 day, then every 24 hours

Secondary Outcomes (1)

• MMSE, CGI, side effect profile, HRV

  12 hours, then every 24 hours

Study Arms (2)

1

EXPERIMENTAL

zotepine , start from 50mg/day then titrate according to individual case

Drug: Risperidone and Zotepine for delirium

2

ACTIVE COMPARATOR

Risperidone, start from 1mg/day

Drug: Risperidone and Zotepine for delirium

Interventions

Risperidone and Zotepine for delirium DRUG

try risperidone or zotepine in the treatment of delirium

Also known as: risperidone( Risperdal), zotepine( Lodopine)

1; 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Related Publications (1)

• 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. doi: 10.1017/s1478951505050352.

  PMID: 16594462 BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Risperidone; zotepine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Cheng-Chen Chang, M.D.

  Changhua Christian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

TW (1)