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Completed

NCT Number: NCT00750087

Non-interventional Study -Observe Treatment Efficacy in Maintaining Symptoms Control in Schizophrenia With Seroquel XR

the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months in patients treated with Seroquel XR.

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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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Alba, Romania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will have a diagnosis of schizophrenia , as defined by DSM-IV-TR and their symptoms are controlled with Seroquel XR therapy started approximately 1 month before
  • All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.

Exclusion criteria

  • All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study.
  • As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.

Treatment and study plan

Primary outcomes

  1. Brief Psychiatric Rating Scale - BPRS

    Time frame: monthly/ at every clinic visit- 7 times

Secondary outcomes

  1. Clinical Global Impression Severity of Illness - CGI -S

    Time frame: monthly/ at every clinic visit- 7 times

  2. Clinical Global Impression Improvement CGI -I

    Time frame: monthly/ at every clinic visit except first visit- 6 times

  3. Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF)

    Time frame: twice/first and last clinic visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 10, 2008
Registry last updated
Feb 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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