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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-07-31

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.

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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.

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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quetiapine

atypical antipsychotic drug

Group Type EXPERIMENTAL

quetiapine

Intervention Type DRUG

25-100 mg

haloperidol

typical antipsychotic drug

Group Type ACTIVE_COMPARATOR

haloperidol

Intervention Type DRUG

0.5-2 mg

Interventions

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quetiapine

25-100 mg

Intervention Type DRUG

haloperidol

0.5-2 mg

Intervention Type DRUG

Other Intervention Names

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seroquel haldol

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No