- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00314184
Quetiapine Fumarate Bipolar Maintenance Monotherapy (SPaRCLe)
Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients
This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Capital Federal, Argentina
- Research Site
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Cordoba, Argentina
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La Plata, Argentina
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Lanus, Argentina
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Mendoza, Argentina
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Rosario, Argentina
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Bourgas, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Antioquia, Colombia
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Barranquilla, Colombia
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Bogota, Colombia
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Pereira, Colombia
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Ahmedabad, India
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Chennai, India
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Jaipur, India
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Kanpur, India
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Lucknow, India
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Mangalore, India
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Manipal, India
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Mumbai, India
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New Delhi, India
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Visakhapatnam, India
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Kaunas, Lithuania
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Klaipeda, Lithuania
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Vilnius, Lithuania
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Kuala Lumpur, Malaysia
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Sarawak, Malaysia
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Leon, Mexico
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Mexico, Mexico
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San Luis Potosi, Mexico
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Lima, Peru
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Cebu City, Philippines
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Davao City, Philippines
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Mandaluyong City, Philippines
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Manila, Philippines
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Quezon City, Philippines
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Arad, Romania
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Brasov, Romania
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Bucuresti, Romania
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Cluj-Napoca, Romania
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Com Jebel, Romania
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Craiova, Romania
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Iasi, Romania
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Oradea, Romania
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Pitesti, Romania
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Sibiu, Romania
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Targoviste, Romania
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Targu Mures, Romania
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Kazan, Russian Federation
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Moscow, Russian Federation
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St. Petersburg, Russian Federation
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Kaohsiung Hsien, Taiwan
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Taipei, Taiwan
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Taoyuan City, Taiwan
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Taoyuan Hsien, Taiwan
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Bangkok, Thailand
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Dnepropetrovsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odessa, Ukraine
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Simferopol, Ukraine
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Vinnitsa, Ukraine
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California
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Cerritos, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Idaho
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Eagle, Idaho, United States
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Illinois
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Hoffman Estates, Illinois, United States
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Indiana
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Terre Haute, Indiana, United States
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Louisiana
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Shreveport, Louisiana, United States
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Mississippi
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Flowood, Mississippi, United States
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Missouri
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St. Charles, Missouri, United States
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Nevada
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Las Vegas, Nevada, United States
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New Jersey
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Clementon, New Jersey, United States
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New York
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Rochester, New York, United States
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North Carolina
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Raleigh, North Carolina, United States
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North Dakota
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Fargo, North Dakota, United States
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Oregon
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Portland, Oregon, United States
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Salem, Oregon, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Tennessee
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Memphis, Tennessee, United States
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Texas
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Austin, Texas, United States
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Lake Jackson, Texas, United States
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Virginia
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Richmond, Virginia, United States
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Washington
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Bellevue, Washington, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent
- 18 years or older
- A diagnosis of Bipolar I Disorder
- Have a current manic, depressed or mixed episode
- Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine
- Female patients of childbearing potential must be using a reliable method of contraception
Exclusion Criteria:
- Pregnancy
- Substance or alcohol dependence at enrollment
- Unstable thyroid function
- Unstable Diabetes
- Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension
- Use of an experimental drug within 30 days of enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Time from randomization to recurrence of a mood event
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Secondary Outcome Measures
Outcome Measure |
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Time from randomization to recurrence of a manic event
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Time from randomization to recurrence of a depressed event
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: AstraZeneca CNS Medical Science Director, MD, AstraZeneca
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1447C00144
- EUDRACT 2004-000915-25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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