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Safety and Efficacy of Switching to Quetiapine in Outpatients With Schizophrenia (Q-chase)

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ClinicalTrials.gov Identifier: NCT00690365
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : December 9, 2010
Information provided by:

Brief Summary:
This is a single-arm, phase IV, open-label, prospective, non interventional study in approximately 600 patients that will be followed for 6 months in order to evaluate the safety and efficacy of quetiapine. Patients will be switched over a 4 to 7 day cross-titration period from their previous antipsychotic medication to quetiapine according to the approved SPC.

Condition or disease

Study Type : Observational
Actual Enrollment : 576 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Non-interventional, Open Label, Phase IV Observational Study for the Safety and Efficacy of Switching to Quetiapine (Seroquel) in Outpatients With Schizophrenia Who Have Been Unsuccessfully Treated With Other Antipsychotics
Study Start Date : June 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Primary Outcome Measures :
  1. Safety of quetiapine assessed through analysis of AE/SAE data (rate of patients presenting SAEs, rate of patients who discontinue treatment due to any AE, time to treatment discontinuation due to any AEs) [ Time Frame: 5 visits (Day 0, Week 1, Week 4, Week 12, Week 24); SAEs will be reported during all study period ]

Secondary Outcome Measures :
  1. Changes in the Clinical Global Impression of Severity and Improvement (CGI-S, CGI-I) and in Brief psychiatric Rating Scale (BPRS) from baseline to end of study treatment [ Time Frame: 5 visits (Day 0, Week 1, Week 4, Week 12, Week 24) ]
  2. Percentage of extra-pyramidal side effects assessed using the Simpson-Angus Scale (SAS) [ Time Frame: Changes from baseline to end of study treatment or (6 months) or early withdrawal ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care

Inclusion Criteria:

  • Diagnosis of schizophrenia at least 1 year prior to screening
  • Inadequate response or poor safety /tolerability or non-compliance to previous antipsychotic medication
  • Provision of Informed Consent prior to enrolment

Exclusion Criteria:

  • Known hypersensitivity to active substance of excipients
  • Patients receiving P450 3A4 inhibitors
  • Pregnancy or lactation
  • Substance abuse or dependence

Responsible Party: Panagiotis Pontikis, MD, Medical & Regulatory Affairs Director, AstraZeneca Greece, AstraZeneca S.A., Greece
ClinicalTrials.gov Identifier: NCT00690365     History of Changes
Other Study ID Numbers: NIS-NGR-SER-2007/1
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
unsuccessfully treated

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Quetiapine Fumarate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs