Dose Finding of Quetiapine Fumarate 200mg vs 400mg in Fir... | NCT00449397

Studies
Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis

NCT00449397

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 27, 2011Estimated

Enrollment

150

Phase

Phase 3

Conditions

Psychosis

Interventions

Quetiapine Fumarate

Countries

Australia

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

Official Title

A Naturalistic, Prospective, Single Centre, Double Blinded, Fixed Dose, Randomised, Four Week Comparison Study Investigating Efficacy, Tolerability and Safety of 200 mg Per Day Versus 400 mg Per Day Quetiapine Fumarate in 200 Drug naïve First Episode Psychosis Patients Aged 15 to 25 Years.

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Jan 2006Actual

Completion Date

Jan 2006Actual

First Submitted Date

Mar 19, 2007

First Submission Date that Met QC Criteria

Mar 19, 2007

First Posted Date

Mar 20, 2007Estimated

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

Jan 25, 2011

Last Update Posted Date

Jan 27, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 determine the minimal effective dose and the impact on:

treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode
the final maintenance doses
the use of other medications
the amount of changes to other antipsychotic medication
the number of hospitalization days

Detailed Description

Not provided

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

150

Name	Type	Description	Arm Group Labels	Other Names
Quetiapine Fumarate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale

Secondary Outcomes

Measure	Description	Time Frame
SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients experiencing their first psychotic episode
Male or Female
Aged 15-25

Exclusion Criteria:

Previous treatment with antipsychotic medication (longer than 1 week)
History of a clinically significant physical illness
Organic disorder presenting with psychotic symptoms

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregor Berger, MD	ORYGEN Research Centre/ ORYGEN Youth Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Sites		Melbourne			Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19324499	Derived	Hides L, Cotton SM, Berger G, Gleeson J, O'Donnell C, Proffitt T, McGorry PD, Lubman DI. The reliability and validity of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in first-episode psychosis. Addict Behav. 2009 Oct;34(10):821-5. doi: 10.1016/j.addbeh.2009.03.001. Epub 2009 Mar 6.
19036233	Derived

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D003987	Dibenzothiazepines
D013841	Thiazepines
D013846	Thiepins
D013457	Sulfur Compounds