SchizophreniaPhase 3NCT00085891
Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
A Phase 3 study testing Quetiapine Fumarate in people with Schizophrenia, run by AstraZeneca at 29 sites in United States.
Trial summary
The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Quetiapine Fumarate
- How many people
- 535 participants
- Where
- 29 sitesUnited States
- Study dates
- Jun 2004to Sep 2005
- 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
- Patient is able to provide written informed consent before beginning any study related procedures
- Patient has a documented clinical diagnosis of schizophrenia
- Patient is able to understand and comply with the requirements of the study, as judged by a study investigator
Who cannot join
- Patients with a history of non-compliance as judged by the study investigator
- Patients with a known lack of response to previous treatment with quetiapine
- Patients who have participated in another drug study within 4 weeks prior to enrollment into this study
- Patients who have previously participated in this study or study D1444C00132
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Research Site
Austin, Texas
Research Site
Birmingham, Alabama
Study site
Brighton, Massachusetts
Research Site
Cerritos, California
Research Site
Holliswood, New York
Research Site
Houston, Texas
Research Site
Irving, Texas
Research Site
Jackson, Mississippi
Research Site
Kirkland, Washington
Research Site
Lawrence, New York
Study site
Los Angeles, California
Research Site
Medina, Ohio
Research Site
Memphis, Tennessee
Research Site
Miami, Florida
Research Site
New Orleans, Louisiana
Research Site
Norristown, Pennsylvania
Study site
Oak Brook, Illinois
Research Site
Oakbrook Terrace, Illinois
Research Site
Oklahoma City, Oklahoma
Research Site
Philadelphia, Pennsylvania
Research Site
Richmond, Virginia
Research Site
Rockville, Maryland
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Santa Ana, California
Research Site
Sioux Falls, South Dakota
Research Site
St Louis, Missouri
Research Site
Staten Island, New York
Research Site
Washington D.C., District of Columbia
About this study
Official title: A 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks.
- Conditions
- Schizophrenia
- Being tested
- Quetiapine Fumarate
- Keywords
- Schizophrenia, Schizophrenic disorder
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine FumarateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.
Secondary outcomes (1)
Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2004 (estimated)
- Study startJun 2004
- Study completionSep 2005
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
- 535 participants
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
- NCT00085891
- Sponsor's protocol ID
- D1444C00133
- Status last verified
- Mar 2009
- First submitted
- 16 Jun 2004
- Last updated
- 25 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00085891
- Acronym / sponsor ID
- D1444C00133
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Schizophrenic disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 18 Jun 2004 (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 demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks.
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)
- Patient is able to provide written informed consent before beginning any study related procedures
- Patient has a documented clinical diagnosis of schizophrenia
- Patient is able to understand and comply with the requirements of the study, as judged by a study investigator
Key exclusion criteria (4 listed)
- Patients with a history of non-compliance as judged by the study investigator
- Patients with a known lack of response to previous treatment with quetiapine
- Patients who have participated in another drug study within 4 weeks prior to enrollment into this study
- Patients who have previously participated in this study or study D1444C00132
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 |
|---|---|---|
| Quetiapine Fumarate | Drug | – |
Primary outcome
Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.
1 secondary outcome
Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline.
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 25 Mar 2009.
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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
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine Fumarate in people with Schizophrenia, run by AstraZeneca at 29 sites in United States.
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 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. 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?
Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.. 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 25 Mar 2009.