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

Phase 3TerminatedNCT00954603

Chiang Mai University52 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Delirium

Interventions

quetiapineDRUG

25-100 mg

haloperidolDRUG

0.5-2 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of psychiatry, faculty of medicine, Chiang Mai university

Chiang Mai, Thailand

Outcomes

Primary Outcomes

decrease in delirium rating scale and clinical global improvement

Time frame: 7 days

Secondary Outcomes

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

Data from ClinicalTrials.gov

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