Study Stopped
few delirious patients were enrolled.
A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium
QHdelirium
Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium
2 other identifiers
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJune 23, 2011
August 1, 2009
1.8 years
August 6, 2009
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
decrease in delirium rating scale and clinical global improvement
7 days
Secondary Outcomes (1)
compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects.
7 days
Study Arms (2)
quetiapine
EXPERIMENTALatypical antipsychotic drug
haloperidol
ACTIVE COMPARATORtypical antipsychotic drug
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of psychiatry, faculty of medicine, Chiang Mai university
Chiang Mai, 50200, Thailand
Related Publications (2)
Maneeton B, Maneeton N, Srisurapanont M. An open-label study of quetiapine for delirium. J Med Assoc Thai. 2007 Oct;90(10):2158-63.
PMID: 18041437RESULTManeeton 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.
PMID: 23926422DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benchalak Maneeton, Assoc Prof
Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 7, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2011
Study Completion
July 1, 2012
Last Updated
June 23, 2011
Record last verified: 2009-08