SchizophreniaPhase 3NCT00206128
Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia
A Phase 3 study testing Seroquel SR in people with Schizophrenia, run by AstraZeneca at 69 sites in 12 countries.
Trial summary
The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Seroquel SR
- How many people
- 454 participants
- Where
- 69 sitesin 12 countries
- Study dates
- Nov 2004to Feb 2006
- Phase
- Phase 3
- 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
Who may be able to join
- A stable dose of quetiapine IR between 300 and 800 mg/day within 4 weeks prior to the enrolment visit (Visit 1) as judged by the investigator.
- Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
- Able to understand and comply with the requirements of the study, as judged by the investigator.
Who cannot join
- Meeting the criteria for any other (than schizophrenia) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I diagnosis, concomitant organic mental disorder or mental retardation.
- Patients with substance abuse or dependence, as defined by DSM-IV, and not in full remission. A urine drug screen test will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.
- Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the investigator.
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
Trial locations and contacts
69 sites in 12 countries.
69 sites in 12 countries
United States18 sites
Research Site
Anaheim, California
Research Site
Atlanta, Georgia
Research Site
Austin, Texas
Research Site
Birmingham, Alabama
Research Site
Cerritos, California
Research Site
Clementon, New Jersey
Research Site
Garden Grove, California
Research Site
Hoffman Estates, Illinois
Research Site
Houston, Texas
Research Site
Jackson, Mississippi
Research Site
National City, California
Research Site
New Orleans, Louisiana
Research Site
North Miami, Florida
Research Site
Pasadena, California
Research Site
Richmond, Virginia
Research Site
San Diego, California
Research Site
Santa Ana, California
Research Site
Staten Island, New York
Canada9 sites
Research Site
Aurora, Ontario
Research Site
Burlington, Ontario
Research Site
Mississauga, Ontario
Research Site
Orléans, Ontario
Research Site
Prince Albert, Saskatchewan
Research Site
Québec, Quebec
Research Site
Sherbrooke, Quebec
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
Germany7 sites
Research Center
Aachen, North Rhine-Westphalia
Research Site
Aachen, North Rhine-Westphalia
Research Site
Göttingen, Lower Saxony
Research Site
Halle
Research Site
Jena, Thuringia
Research Site
Marburg
Research Site
München, Bavaria
Italy7 sites
Research Site
Bassano del Grappa, VI
Research Site
Bologna, BO
Research Site
Cagliari, CA
Research Site
Città di Castello, PG
Research Site
Ellera Di Corciano, PG
Research Site
Quartu Sant'Elena, CA
Research Site
Torino, TO
Hungary6 sites
Research Site
Budapest
Research Site
Debrecen
Research Site
Gyula
Research Site
Nagykálló
Research Site
Szeged
Research Site
Székesfehérvár
Spain6 sites
Research Site
Alcobendas, Madrid
Research Site
Colmenar Viejo, Madrid
Research Site
Jerez de la Frontera, Cádiz
Research Site
Madrid, Madrid
Research Site
Móstoles, Madrid
Research Site
Villamartín
Lithuania4 sites
Research Site
Klapeda
Research Site
Šiauliai
Research Sitte
Vilnius
Research Site
Ziegzdrai, Kaunas County
Estonia3 sites
Research Site
Põltsamaa
Research Site
Tallinn
Research Site
Tartu
About this study
Official title: 6-week Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Evaluate the Feasibility of Switching From Immediate-release Quetiapine Fumarate (SEROQUEL) to Sustained-release Quetiapine Fumarate in Outpatients With Schizophrenia (Abbreviated)
The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
- Conditions
- Schizophrenia
- Being tested
- Seroquel SR
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seroquel SRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more
Measured: from randomisation to any visit
Secondary outcomes (3)
The change in PANSS total score
Measured: from randomization to week 6
The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
Measured: from randomization to week 6
The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4
Measured: at week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionFeb 2006
- Study completionFeb 2006
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Seroquel Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206128
- Sponsor's protocol ID
- D1444C00146
- Status last verified
- Jan 2013
- First submitted
- 13 Sep 2005
- Last updated
- 4 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6-week Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Evaluate the Feasibility of Switching From Immediate-release Quetiapine Fumarate (SEROQUEL) to Sustained-release Quetiapine Fumarate in Outpatients With Schizophrenia (Abbreviated)
- ClinicalTrials.gov ID
- NCT00206128
- Acronym / sponsor ID
- D1444C00146
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 21 Sep 2005 (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.
The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A stable dose of quetiapine IR between 300 and 800 mg/day within 4 weeks prior to the enrolment visit (Visit 1) as judged by the investigator.
- Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
- Able to understand and comply with the requirements of the study, as judged by the investigator.
Key exclusion criteria (4 listed)
- Meeting the criteria for any other (than schizophrenia) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I diagnosis, concomitant organic mental disorder or mental retardation.
- Patients with substance abuse or dependence, as defined by DSM-IV, and not in full remission. A urine drug screen test will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.
- Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the investigator.
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seroquel SR | Drug | – |
Primary outcome
The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more
Time frame: from randomisation to any visit
3 secondary outcomes
The change in PANSS total score
Time frame: from randomization to week 6
The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
Time frame: from randomization to week 6
The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4
Time frame: at week 6
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 4 Jan 2013.
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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.
AstraZeneca Seroquel Medical Science Director, MD study director
AstraZeneca
69 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seroquel SR in people with Schizophrenia, run by AstraZeneca at 69 sites in 12 countries.
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 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Canada, Germany, Italy, Hungary and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more (time frame: from randomisation to any visit). 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 4 Jan 2013.