SchizophreniaQ-chaseNCT00690365
Safety and Efficacy of Switching to Quetiapine in Outpatients With Schizophrenia
An observational study of Schizophrenia, run by AstraZeneca.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 576 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care
Who may be able to join
- 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
Who cannot join
- Known hypersensitivity to active substance of excipients
- Patients receiving P450 3A4 inhibitors
- Pregnancy or lactation
- Substance abuse or dependence
About this study
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
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.
- Conditions
- Schizophrenia
- Keywords
- Switching, Quetiapine, schizophrenia, unsuccessfully treated, antipsychotics
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 visits (Day 0, Week 1, Week 4, Week 12, Week 24); SAEs will be reported during all study period
Secondary outcomes (2)
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
Measured: 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)
Measured: Changes from baseline to end of study treatment or (6 months) or early withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690365
- Sponsor's protocol ID
- NIS-NGR-SER-2007/1
- Acronym
- Q-chase
- Status last verified
- Dec 2010
- First submitted
- 2 Jun 2008
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00690365
- Acronym / sponsor ID
- Q-chase / NIS-NGR-SER-2007/1
- Conditions
- Schizophrenia
- Keywords
- Switching, Quetiapine, schizophrenia, unsuccessfully treated, antipsychotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Known hypersensitivity to active substance of excipients
- Patients receiving P450 3A4 inhibitors
- Pregnancy or lactation
- Substance abuse or dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2010.