A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium (QHdelirium)
This study has been terminated.
(few delirious patients were enrolled.)
Sponsor:
Chiang Mai University
Information provided by:
Chiang Mai University
ClinicalTrials.gov Identifier:
NCT00954603
First received: August 6, 2009
Last updated: June 22, 2011
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Delirium |
Drug: quetiapine Drug: haloperidol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium |
Resource links provided by NLM:
Further study details as provided by Chiang Mai University:
Primary Outcome Measures:
- decrease in delirium rating scale and clinical global improvement [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 52 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | July 2012 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: quetiapine
atypical antipsychotic drug
|
Drug: quetiapine
25-100 mg
Other Name: seroquel
|
|
Active Comparator: haloperidol
typical antipsychotic drug
|
Drug: haloperidol
0.5-2 mg
Other Name: haldol
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954603
Locations
| Thailand | |
| Department of psychiatry, faculty of medicine, Chiang Mai university | |
| Chiang Mai, Thailand, 50200 | |
Sponsors and Collaborators
Chiang Mai University
Investigators
| Principal Investigator: | Benchalak Maneeton, Assoc Prof | Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand |
More Information
Additional Information:
Publications:
| Responsible Party: | Associate prof. Benchalak Maneeton, department of psychiatry, faculty of medicine, Chiang mai university, Thailand |
| ClinicalTrials.gov Identifier: | NCT00954603 History of Changes |
| Other Study ID Numbers: | MedCMU Que vs Halo - 2008, Que vs Halo - 2008 |
| Study First Received: | August 6, 2009 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Thailand: Ethical Conduct of Research Involving humans(Research Ethics Committee)Faculty of medicine, Chiang Mai university, Chiang Mai Thailand: Ministry of Public Health |
Keywords provided by Chiang Mai University:
|
delirium rating scale clinical global improvement extrapyramidal side effect |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Haloperidol Haloperidol decanoate Quetiapine Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents |
ClinicalTrials.gov processed this record on June 17, 2013