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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium

Conditions
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Delirium

Intervention / Treatment
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* Drug: quetiapine
* Drug: haloperidol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: quetiapine<br>atypical antipsychotic drug | Drug: quetiapine<br>* 25-100 mg<br>* Other names: seroquel;|
| Active Comparator: haloperidol<br>typical antipsychotic drug | Drug: haloperidol<br>* 0.5-2 mg<br>* Other names: haldol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in delirium rating scale and clinical global improvement |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects. |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delirium rating scale, clinical global improvement, extrapyramidal side effect