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

Primary Purpose

Delirium

Status
Terminated
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
quetiapine
haloperidol
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring delirium rating scale, clinical global improvement, extrapyramidal side effect

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of psychiatry, faculty of medicine, Chiang Mai university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

quetiapine

haloperidol

Arm Description

atypical antipsychotic drug

typical antipsychotic drug

Outcomes

Primary Outcome Measures

decrease in delirium rating scale and clinical global improvement

Secondary Outcome Measures

compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects.

Full Information

First Posted
August 6, 2009
Last Updated
June 22, 2011
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT00954603
Brief Title
A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium
Acronym
QHdelirium
Official Title
Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
few delirious patients were enrolled.
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chiang Mai University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
delirium rating scale, clinical global improvement, extrapyramidal side effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
quetiapine
Arm Type
Experimental
Arm Description
atypical antipsychotic drug
Arm Title
haloperidol
Arm Type
Active Comparator
Arm Description
typical antipsychotic drug
Intervention Type
Drug
Intervention Name(s)
quetiapine
Other Intervention Name(s)
seroquel
Intervention Description
25-100 mg
Intervention Type
Drug
Intervention Name(s)
haloperidol
Other Intervention Name(s)
haldol
Intervention Description
0.5-2 mg
Primary Outcome Measure Information:
Title
decrease in delirium rating scale and clinical global improvement
Time Frame
7 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benchalak Maneeton, Assoc Prof
Organizational Affiliation
Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of psychiatry, faculty of medicine, Chiang Mai university
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
18041437
Citation
Maneeton B, Maneeton N, Srisurapanont M. An open-label study of quetiapine for delirium. J Med Assoc Thai. 2007 Oct;90(10):2158-63.
Results Reference
result
PubMed Identifier
23926422
Citation
Maneeton B, Maneeton N, Srisurapanont M, Chittawatanarat K. Quetiapine versus haloperidol in the treatment of delirium: a double-blind, randomized, controlled trial. Drug Des Devel Ther. 2013 Jul 24;7:657-67. doi: 10.2147/DDDT.S45575. Print 2013.
Results Reference
derived
Links:
URL
http://emedicine.medscape.com/article/288890-treatment
Description
treatment delirium
URL
http://www.icudelirium.org/
Description
treatment delirium
URL
http://www.psychiatryonline.com/pracGuide/loadGuidelinePdf.aspx?file=DeliriumPG_05-15-06
Description
treatment delirium
URL
http://en.wikipedia.org/wiki/Delirium#Treatment
Description
treatment delirium
URL
http://www.cochrane.org/reviews/en/ab005594.html
Description
treatment delirium

Learn more about this trial

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

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