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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Seroquel (quetiapine) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

Summary

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.

Clinical Details

Official title: A 1-year, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Phase 3 Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Sustained-release Quetiapine Fumarate (SEROQUEL) or Placebo (Abbreviated)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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 outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 and Contacts

Investigative Site, Burgas, Bulgaria

Investigative Site, Radnevo, Bulgaria

Investigative Site, Sofia, Bulgaria

Investigative Site, Bydgoszcz, Poland

Investigative Site, Tuszyn, Poland

Additional Information

Starting date: March 2005
Last updated: January 3, 2013

Page last updated: August 23, 2015

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