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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690365
First received: June 2, 2008
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

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
Schizophrenia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ]
  • 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 ]

Enrollment: 576
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care

Criteria

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
  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.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: June 2, 2008
Last Updated: December 8, 2010
Health Authority: Greece: National Organization of Medicines

Keywords provided by AstraZeneca:
Switching
Quetiapine
schizophrenia
unsuccessfully treated
antipsychotics

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

ClinicalTrials.gov processed this record on November 24, 2014