Seroquel XR in Schizophrenia Relapse Prevention | NCT00990626 | Trialant

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Seroquel XR in Schizophrenia Relapse Prevention | NCT00990626 | Trialant

Studies
Seroquel XR in Schizophrenia Relapse Prevention

NCT00990626

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Nov 17, 2010Estimated

Enrollment

1,600Estimated

Phase

Not provided

Conditions

Schizophrenia Relapse Prevention

Interventions

Not provided

Countries

Hungary

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

NCT00990626

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

NIS-NHU-SER-2009/1

Secondary IDs

Not provided

Brief Title

Seroquel XR in Schizophrenia Relapse Prevention

Official Title

Seroquel XR in Schizophrenia Relapse Prevention

Acronym

Not provided

Organization

AstraZenecaINDUSTRY

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Oct 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Oct 1, 2009

First Submission Date that Met QC Criteria

Oct 6, 2009

First Posted Date

Oct 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

Nov 16, 2010

Last Update Posted Date

Nov 17, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

AstraZenecaINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

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 the study is to determine whether the Seroquel XR treatment for 6 months improve the relapse prevention in schizophrenic outpatients

Detailed Description

Not provided

Conditions Module

Conditions

Schizophrenia Relapse Prevention

Keywords

Seroquel XR
schizophrenia relapse prevention

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Schizophrenic outpatients

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of patients remained relapse free after 6 months of treatment

Secondary Outcomes

Measure	Description	Time Frame
Adherence rate of patients
Quality of Life (QoL )

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Schizophrenic outpatients on at least 600 mg Seroquel XR treatment for at least 1 month

Exclusion Criteria:

Severe cerebro- and cardiovascular disease, severe hepatic impairment, gravidity

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Psychiatric outpatient clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Attila Németh	National Psychiatric Centre	Principal Investigator
Lilla Szabó	AstraZeneca Hungary MC	Study Chair
Tamás Bábel	AstraZeneca Hungary MC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Baja			Hungary
Research Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Cohort

Time Perspective

Prospective

Masking Info

No data available

No data is available for this block.

Barcs

Hungary

Research Site

Budapest

Hungary

Research Site

Cegléd

Hungary

Research Site

Debrecen

Hungary

Research Site

Dombóvár

Hungary

Research Site

Dunaújváros

Hungary

Research Site

Eger

Hungary

Research Site

Egerszalók

Hungary

Research Site

Emőd

Hungary

Research Site

Esztergom

Hungary

Research Site

Érd

Hungary

Research Site

Gödöllő

Hungary

Research Site

Gyöngyös

Hungary

Research Site

Győr

Hungary

Research Site

Gyula

Hungary

Research Site

Heves

Hungary

Research Site

Hódmezővásárhely

Hungary

Research Site

Jánoshalma

Hungary

Research Site

Jászberény

Hungary

Research Site

Kalocsa

Hungary

Research Site

Kecskemét

Hungary

Research Site

Kétegyháza

Hungary

Research Site

Kiskunhalas

Hungary

Research Site

Kistokaj

Hungary

Research Site

Miskolc

Hungary

Research Site

Nagyatád

Hungary

Research Site

Nagykanizsa

Hungary

Research Site

Nagykálló

Hungary

Research Site

Nagykőrös

Hungary

Research Site

Orosháza

Hungary

Research Site

Pécs

Hungary

Research Site

Pomáz

Hungary

Research Site

Sátoraljaújhely

Hungary

Research Site

Soltvadkert

Hungary

Research Site

Sopron

Hungary

Research Site

Sümeg

Hungary

Research Site

Szeged

Hungary

Research Site

Szeghalom

Hungary

Research Site

Szekszárd

Hungary

Research Site

Szentes

Hungary

Research Site

Székesfehérvár

Hungary

Research Site

Szigetszentmiklós

Hungary

Research Site

Szigetvár

Hungary

Research Site

Szolnok

Hungary

Research Site

Szombathely

Hungary

Research Site

Tatabánya

Hungary

Research Site

Veszprém

Hungary