A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium
Information source: Chiang Mai University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Delirium
Intervention: quetiapine (Drug); haloperidol (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Chiang Mai University Official(s) and/or principal investigator(s): Benchalak Maneeton, Assoc Prof, Principal Investigator, Affiliation: Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand
Summary
The purpose of this study is to determine whether quetiapine, and haloperidol are effective
and safe in the treatment psychiatric symptoms in patients with delirium.
Clinical Details
Official title: Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: decrease in delirium rating scale and clinical global improvement
Secondary outcome: compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects.
Detailed description:
A delirious state often founds in general hospitals and remains a significant cause of
death. Existing methods of treatment includes identification and elimination of factors
contributing to the delirium in addition to pharmacological and nonpharmacological treatment
interventions (Trzepacz et al., 1999). Antipsychotics can play an important role in the
management of the symptoms of delirium.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female age 18 -75 years
- Was admitted in Maharaj Nakhon Chiang Mai hospital
- Was diagnosed by the diagnostic criteria for DSM-IV-TR delirium due to a general
medical condition or delirium due to multiple etiologies
- Delirious state (delirium) of the patients was confirmed by using name-assess
confusion assessment method (CAM) and assessment of severity with delirium rating
scale-revised-98 (DRS-R-98)
- Have a written consent from the legal representatives
Exclusion Criteria:
- Was diagnosed substance withdrawal delirium
- Having a history drug allergy either from quetiapine or haloperidol
- Female patients who are pregnant or breastfeeding
- No written consent from the legal representatives
- Received other anti-psychotic drug before attend the study
- Being ill with renal or hepatic failure
Locations and Contacts
Department of psychiatry, faculty of medicine, Chiang Mai university, Chiang Mai 50200, Thailand
Additional Information
treatment delirium treatment delirium treatment delirium treatment delirium
Starting date: June 2009
Last updated: June 22, 2011
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