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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.)
Information provided by:
Chiang Mai University Identifier:
First received: August 6, 2009
Last updated: June 22, 2011
Last verified: August 2009
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.

Condition Intervention Phase
Drug: quetiapine
Drug: haloperidol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium

Resource links provided by NLM:

Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • decrease in delirium rating scale and clinical global improvement [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: June 2009
Estimated Study Completion Date: July 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: quetiapine
atypical antipsychotic drug
Drug: quetiapine
25-100 mg
Other Name: seroquel
Active Comparator: haloperidol
typical antipsychotic drug
Drug: haloperidol
0.5-2 mg
Other Name: haldol

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00954603

Department of psychiatry, faculty of medicine, Chiang Mai university
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Principal Investigator: Benchalak Maneeton, Assoc Prof Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Associate prof. Benchalak Maneeton, department of psychiatry, faculty of medicine, Chiang mai university, Thailand Identifier: NCT00954603     History of Changes
Other Study ID Numbers: MedCMU Que vs Halo - 2008
Que vs Halo - 2008 ( Other Identifier: 077/2552 )
Study First Received: August 6, 2009
Last Updated: June 22, 2011

Keywords provided by Chiang Mai University:
delirium rating scale
clinical global improvement
extrapyramidal side effect

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Quetiapine Fumarate
Haloperidol decanoate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents processed this record on April 28, 2017