A Double-blind, Randomized, Controlled Trial of Quetiapin... | NCT00954603

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

NCT00954603

Sponsor

Chiang Mai University

Status

Terminated

Last Update Posted

Jun 23, 2011Estimated

Enrollment

52Actual

Phase

Phase 3

Conditions

Delirium

Interventions

quetiapine
haloperidol

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Que vs Halo - 2008	Other Identifier	077/2552

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

few delirious patients were enrolled.

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Apr 2011Actual

Completion Date

Jul 2012Estimated

First Submitted Date

Aug 6, 2009

First Submission Date that Met QC Criteria

Aug 6, 2009

First Posted Date

Aug 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
quetiapine	Experimental	atypical antipsychotic drug	Drug: quetiapine
haloperidol	Active Comparator	typical antipsychotic drug	Drug: haloperidol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
quetiapine	Drug	25-100 mg	quetiapine	seroquel

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benchalak Maneeton, Assoc Prof	Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of psychiatry, faculty of medicine, Chiang Mai university		Chiang Mai		50200	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18041437	Result	Maneeton B, Maneeton N, Srisurapanont M. An open-label study of quetiapine for delirium. J Med Assoc Thai. 2007 Oct;90(10):2158-63.
23926422	Derived	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.

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D003987	Dibenzothiazepines
D013841	Thiazepines
D013846	Thiepins
D013457	Sulfur Compounds

ID	Term
D000069348	Quetiapine Fumarate
D006220	Haloperidol