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

This study has been terminated.
(few delirious patients were enrolled.)
Sponsor:
Information provided by:
Chiang Mai University
ClinicalTrials.gov Identifier:
NCT00954603
First received: August 6, 2009
Last updated: June 22, 2011
Last verified: August 2009

August 6, 2009
June 22, 2011
June 2009
April 2011   (final data collection date for primary outcome measure)
decrease in delirium rating scale and clinical global improvement [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00954603 on ClinicalTrials.gov Archive Site
compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium
Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Delirium
  • Drug: quetiapine
    25-100 mg
    Other Name: seroquel
  • Drug: haloperidol
    0.5-2 mg
    Other Name: haldol
  • Experimental: quetiapine
    atypical antipsychotic drug
    Intervention: Drug: quetiapine
  • Active Comparator: haloperidol
    typical antipsychotic drug
    Intervention: Drug: haloperidol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
52
July 2012
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00954603
MedCMU Que vs Halo - 2008, Que vs Halo - 2008
Yes
Associate prof. Benchalak Maneeton, department of psychiatry, faculty of medicine, Chiang mai university, Thailand
Chiang Mai University
Not Provided
Principal Investigator: Benchalak Maneeton, Assoc Prof Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand
Chiang Mai University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP