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Trial record 73 of 450 for:    QUETIAPINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00954603
Recruitment Status : Terminated (few delirious patients were enrolled.)
First Posted : August 7, 2009
Last Update Posted : June 23, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Delirium Drug: quetiapine Drug: haloperidol Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium
Study Start Date : June 2009
Actual Primary Completion Date : April 2011
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00954603

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

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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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 )
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: August 2009
Keywords provided by Chiang Mai University:
delirium rating scale
clinical global improvement
extrapyramidal side effect
Additional relevant MeSH terms:
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Quetiapine Fumarate
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Haloperidol decanoate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents