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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


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
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