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A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium

Phase 3
Terminated
Conditions
Delirium
Interventions
Registration Number
NCT00954603
Lead Sponsor
Chiang Mai University
Brief 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.

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
52
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
quetiapinequetiapineatypical antipsychotic drug
haloperidolhaloperidoltypical antipsychotic drug
Primary Outcome Measures
NameTimeMethod
decrease in delirium rating scale and clinical global improvement7 days
Secondary Outcome Measures
NameTimeMethod
compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects.7 days

Trial Locations

Locations (1)

Department of psychiatry, faculty of medicine, Chiang Mai university

🇹🇭

Chiang Mai, Thailand

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