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

Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00954603

Acronym

QHdelirium

Enrollment

Registered

2009-08-07

Start date

2009-06-30

Completion date

2012-07-31

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

delirium rating scale, clinical global improvement, extrapyramidal side effect

Brief summary

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

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.

Interventions

DRUGquetiapine

25-100 mg

DRUGhaloperidol

0.5-2 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
decrease in delirium rating scale and clinical global improvement	7 days

Secondary

Measure	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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026