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
  Purpose

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
Delirium
Drug: quetiapine
Drug: haloperidol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954603

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Associate prof. Benchalak Maneeton, department of psychiatry, faculty of medicine, Chiang mai university, Thailand
ClinicalTrials.gov Identifier: NCT00954603     History of Changes
Other Study ID Numbers: MedCMU Que vs Halo - 2008, Que vs Halo - 2008
Study First Received: August 6, 2009
Last Updated: June 22, 2011
Health Authority: Thailand: Ethical Conduct of Research Involving humans(Research Ethics Committee)Faculty of medicine, Chiang Mai university, Chiang Mai
Thailand: Ministry of Public Health

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

Additional relevant MeSH terms:
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Haloperidol
Haloperidol decanoate
Quetiapine
Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014