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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00750087
First received: September 9, 2008
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

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.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Brief Psychiatric Rating Scale - BPRS [ Time Frame: monthly/ at every clinic visit- 7 times ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Severity of Illness - CGI -S [ Time Frame: monthly/ at every clinic visit- 7 times ] [ Designated as safety issue: No ]
  • Clinical Global Impression Improvement CGI -I [ Time Frame: monthly/ at every clinic visit except first visit- 6 times ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF) [ Time Frame: twice/first and last clinic visit ] [ Designated as safety issue: No ]

Enrollment: 578
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Schizophrenia patients stabilized on Seroquel XR

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The programme will include schizophrenia patients stabilized on Seroquel XR from community sample

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750087

Locations
Romania
Research Site
Alba, Romania
Research Site
Arad, Romania
Research Site
Bacau, Romania
Research Site
Baia Mare, Romania
Research Site
Bistrita, Romania
Research Site
Botosani, Romania
Research Site
Braila, Romania
Research Site
Brasov, Romania
Research Site
Bucuresti, Romania
Research Site
Calarasi, Romania
Research Site
Campina, Romania
Research Site
Cluj, Romania
Research Site
Cluj Napoca, Romania
Research Site
Constanta, Romania
Research Site
Craiova, Romania
Research Site
Deva, Romania
Research Site
Galati, Romania
Research Site
Giurgiu, Romania
Research Site
Horezu, Romania
Research Site
Iasi, Romania
Research Site
Oradea, Romania
Research Site
Pitesti, Romania
Research Site
Ploiesti, Romania
Research Site
Ramnicu Valcea, Romania
Research Site
Satu Mare, Romania
Research Site
Sibiu, Romania
Research Site
Siret, Romania
Research Site
Slatina, Romania
Research Site
Slobozia, Romania
Research Site
Targoviste, Romania
Research Site
Targu Mures, Romania
Research Site
Timisoara, Romania
Research Site
Zalau, Romania
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Beatrice Costea AstraZeneca
  More Information

No publications provided

Responsible Party: Hans Eriksson - Medical Science Director, AstraZeenca
ClinicalTrials.gov Identifier: NCT00750087     History of Changes
Other Study ID Numbers: NIS-NRO-SER-2008/1
Study First Received: September 9, 2008
Last Updated: February 4, 2010
Health Authority: Romania: National Medicines Agency

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 20, 2014