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SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia

NCT ID: NCT00206115

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

535 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-12-31

Brief Summary

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The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained Release (SR) is more effective than placebo in the treatment of acute schizophrenia.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

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Detailed Description

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Conditions

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Schizophrenic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Seroquel Sustained Release (SR)

Intervention Type DRUG

Seroquel Immediate Release (IR)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* To be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate.

Exclusion Criteria

* Patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and dependence, or medical conditions such as specific kidney, heart or thyroid problems, and patients with a known lack of response to drugs for schizophrenia will not be considered for this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca CNS Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Burgas, , Bulgaria

Site Status

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia- Novi Iskar, , Bulgaria

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Athens, , Greece

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Chania, , Greece

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Corfu, , Greece

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Thessaloniki, , Greece

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Chennai, , India

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Karnataka, , India

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Lucknow, , India

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New Delhi, , India

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Jakarta, DKI Jakarta, Indonesia

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Bandung, West Java, Indonesia

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Surabaya, , Indonesia

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Cebu, , Philippines

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Davao City, , Philippines

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Mandaluyong, , Philippines

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Manila, , Philippines

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Pasig, , Philippines

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Brasov, , Romania

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Bucharest, , Romania

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Moscow, , Russia

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Saint Petersburg, , Russia

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Johannesburg, Gauteng, South Africa

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Medunsa, Pretoria, South Africa

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Bloemfontein, , South Africa

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Ga-Rankuwa, , South Africa

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Johannesburg, , South Africa

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Research Site

Lyttelton Manor, , South Africa

Site Status

Research Site

Pretoria, , South Africa

Site Status

Countries

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Bulgaria Greece India Indonesia Philippines Romania Russia South Africa

References

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Kahn RS, Schulz SC, Palazov VD, Reyes EB, Brecher M, Svensson O, Andersson HM, Meulien D; Study 132 Investigators. Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2007 Jun;68(6):832-42. doi: 10.4088/jcp.v68n0603.

Reference Type DERIVED
PMID: 17592906 (View on PubMed)

Other Identifiers

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D1444C00132

Identifier Type: -

Identifier Source: org_study_id

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