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

Chiang Mai University

Status and phase: Terminated; Phase 3

Conditions: Delirium

Treatments: Drug: haloperidol; Drug: quetiapine

Study type: Interventional

Funder types: Other

Identifiers

NCT00954603

MedCMU Que vs Halo - 2008

Que vs Halo - 2008 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups

quetiapine

Experimental group

Description:

atypical antipsychotic drug

Treatment:

Drug: quetiapine

haloperidol

Active Comparator group

Description:

typical antipsychotic drug

Treatment:

Drug: haloperidol