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

Delirium Clinical Trial

— QHdelirium  

Official title:

Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00954603
• Other study ID #: MedCMU Que vs Halo - 2008
• Secondary ID: Que vs Halo - 20
• Status: Terminated
• Phase: Phase 3
• First received: August 6, 2009
• Last updated: June 22, 2011
• Start date: June 2009
• Est. completion date: July 2012

Study information

• Verified date: August 2009
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Conduct of Research Involving humans(Research Ethics Committee)Faculty of medicine, Chiang Mai university, Chiang MaiThailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: July 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• quetiapine
25-100 mg
• haloperidol
0.5-2 mg

Locations

Country	Name	City	State
Thailand	Department of psychiatry, faculty of medicine, Chiang Mai university	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Maneeton B, Maneeton N, Srisurapanont M. An open-label study of quetiapine for delirium. J Med Assoc Thai. 2007 Oct;90(10):2158-63. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in delirium rating scale and clinical global improvement		7 days	Yes
Secondary	compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects.		7 days	Yes

External Links

•   treatment delirium
•   treatment delirium
•   treatment delirium
•   treatment delirium
•   treatment delirium