SchizophreniaPhase 4NCT00034905
A Comparison of Seroquel vs. Risperidone in Schizophrenia
A Phase 4 study testing quetiapine fumarate vs risperidone in people with Schizophrenia, run by AstraZeneca at 64 sites in United States.
Trial summary
The purpose of this study is to show equal efficacy of both quetiapine and risperidone in subjects treated with study medication for up to 8 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 vs risperidone
- How many people
- Not given
- Where
- 64 sitesUnited States
- Study dates
- Jul 2001to Sep 2002
- Phase
- Phase 4
- 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
- Male / Female, 18-65 years old
- Schizophrenia (as per DSM IV)
Who cannot join
- Concurrent use of psychotropic medication
- Does not fulfill moderately ill on CGI
Trial locations and contacts
64 sites in 1 country.
64 sites in 1 country
United States64 sites
Study site
Albuquerque, New Mexico
Study site
Anaheim, California
Study site
Ann Arbor, Michigan
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Beachwood, Ohio
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Butner, North Carolina
Study site
Cerritos, California
Study site
Chagrin Falls, Ohio
Study site
Chula Vista, California
Study site
Cincinnati, Ohio
Study site
Clementon, New Jersey
Study site
Columbus, Ohio
Study site
Falls Church, Virginia
Study site
Farmington, Connecticut
Study site
Glendale, California
Study site
Hawthorne, California
Study site
Hoffman Estates, Illinois
Study site
Holliswood, New York
Study site
Houston, Texas
Study site
Kansas City, Missouri
Study site
Kirkland, Washington
Study site
Long Beach, California
Study site
Lyons, New Jersey
Study site
Media, Pennsylvania
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Miami Beach, Florida
Study site
Montrose, New York
Study site
Nashville, Tennessee
Study site
New Baltimore, Michigan
Study site
New Haven, Connecticut
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
North Miami, Florida
Study site
Oceanside, New York
Study site
Oklahoma City, Oklahoma
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Prairie Village, Kansas
Study site
Reno, Nevada
Study site
Richmond, Virginia
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
Santa Ana, California
Study site
Shreveport, Louisiana
Study site
St Louis, Missouri
Study site
Summit, New Jersey
Study site
Tacoma, Washington
Study site
Terrell, Texas
Study site
The Bronx, New York
Study site
Torrance, California
Study site
Vancouver, Washington
Study site
Virginia Beach, Virginia
Study site
Waco, Texas
Study site
Washington D.C., District of Columbia
Study site
West Allis, Wisconsin
Study site
White Plains, New York
Study site
Wichita, Kansas
Study site
Winter Park, Florida
Study site
Worcester, Massachusetts
About this study
The purpose of this study is to show equal efficacy of both quetiapine and risperidone in subjects treated with study medication for up to 8 weeks.
- Conditions
- Schizophrenia
- Being tested
- quetiapine fumarate vs risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapine fumarate vs risperidoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startJul 2001
- Primary completionSep 2002
- Study completionSep 2002
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 4
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034905
- Sponsor's protocol ID
- 5077US/0043
- Status last verified
- Jan 2013
- First submitted
- 2 May 2002
- 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
- A Comparison of Seroquel vs. Risperidone in Schizophrenia
- ClinicalTrials.gov ID
- NCT00034905
- Acronym / sponsor ID
- 5077US/0043
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- Sep 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 3 May 2002 (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 show equal efficacy of both quetiapine and risperidone in subjects treated with study medication for up to 8 weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male / Female, 18-65 years old
- Schizophrenia (as per DSM IV)
Key exclusion criteria (2 listed)
- Concurrent use of psychotropic medication
- Does not fulfill moderately ill on CGI
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 vs risperidone | Drug | – |
Primary outcome
Not reported in the source record.
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.
The record lists no contact. Use the official record to reach the sponsor.
64 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing quetiapine fumarate vs risperidone in people with Schizophrenia, run by AstraZeneca at 64 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 2 inclusion and 2 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 64 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
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.