Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo

NCT ID: NCT00228462

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

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-04-30

Brief Summary

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This study is being carried out to see if quetiapine (Seroquel) is effective in preventing patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it compares with non-active treatment.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Seroquel (quetiapine)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stable schizophrenic patients who have provided written informed consent
* Patients 18 to 65 years old who remain clinically stable after switching to a stable dose of Seroquel (quetiapine).

Exclusion Criteria

* Patients with risk of suicide, other disorders or substance abuse that might interfere with the patient's ability to co-operate,
* Expected non-compliance to treatment
* Known diabetes mellitus,
* Contraindications,
* Intolerance or non-responsiveness to Seroquel or other safety issues.
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 Seroquel Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Investigative Site

Burgas, , Bulgaria

Site Status

Investigative Site

Radnevo, , Bulgaria

Site Status

Investigative Site

Sofia, , Bulgaria

Site Status

Investigative Site

Bydgoszcz, , Poland

Site Status

Investigative Site

Tuszyn, , Poland

Site Status

Countries

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Bulgaria Poland

Other Identifiers

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D1444C00004

Identifier Type: -

Identifier Source: org_study_id

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