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

June 22, 2011 updated by: Chiang Mai University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Chiang Mai, Thailand, 50200
        • Department of Psychiatry, Faculty of Medicine, Chiang Mai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: quetiapine
atypical antipsychotic drug
Drug: quetiapine
25-100 mg
Other Names:
  • seroquel
Active Comparator: haloperidol
typical antipsychotic drug
Drug: haloperidol
0.5-2 mg
Other Names:
  • haldol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
decrease in delirium rating scale and clinical global improvement
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Benchalak Maneeton, Assoc Prof, Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (Estimate)

August 7, 2009

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedCMU Que vs Halo - 2008
  • Que vs Halo - 2008 (Other Identifier: 077/2552)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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