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

AstraZeneca197 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

197

Conditions

Schizophrenia

Interventions

Seroquel (quetiapine)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (5)

Investigative Site

Burgas, Bulgaria

Investigative Site

Radnevo, Bulgaria

Investigative Site

Sofia, Bulgaria

Investigative Site

Bydgoszcz, Poland

Investigative Site

Tuszyn, Poland

Outcomes

Primary Outcomes

The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating relapse prevention in long-term use in patients with schizophrenia as measured by the time to first psychiatric relapse up to one year

Secondary Outcomes

To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse in long-term use in patients with schizophrenia by evaluating the one-year relapse rate

Data from ClinicalTrials.gov

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