Clinical trial NCT00954603: A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium
Official title: Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Delirium
Keywords: delirium rating scale
clinical global improvement
extrapyramidal side effect
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2009-08-07
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: decrease in delirium rating scale and clinical global improvement
timeFrame: 7 days
Secondary outcomes:
measure: compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects.
timeFrame: 7 days
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of psychiatry, faculty of medicine, Chiang Mai university
Study officials:
affiliation: Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand
name: Benchalak Maneeton, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maneeton B, Maneeton N, Srisurapanont M. An open-label study of quetiapine for delirium. J Med Assoc Thai. 2007 Oct;90(10):2158-63.
citation: Maneeton B, Maneeton N, Srisurapanont M, Chittawatanarat K. Quetiapine versus haloperidol in the treatment of delirium: a double-blind, randomized, controlled trial. Drug Des Devel Ther. 2013 Jul 24;7:657-67. doi: 10.2147/DDDT.S45575. Print 2013.