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
2 other identifiers
interventional
1,255
15 countries
95
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2005
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 11, 2006
CompletedFirst Posted
Study publicly available on registry
April 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedDecember 22, 2008
December 1, 2008
April 11, 2006
December 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from randomization to recurrence of a mood event
Secondary Outcomes (2)
Time from randomization to recurrence of a manic event
Time from randomization to recurrence of a depressed event
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (95)
Research Site
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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Washington D.C., District of Columbia, United States
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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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Atlanta, Georgia, United States
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Eagle, Idaho, United States
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Hoffman Estates, Illinois, United States
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Terre Haute, Indiana, United States
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Shreveport, Louisiana, United States
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Flowood, Mississippi, United States
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Saint Charles, Missouri, United States
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Las Vegas, Nevada, United States
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Clementon, New Jersey, United States
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Rochester, New York, United States
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Raleigh, North Carolina, United States
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Fargo, North Dakota, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Lake Jackson, Texas, United States
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Richmond, Virginia, United States
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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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Capital Federal, Argentina
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Córdoba, Argentina
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La Plata, Argentina
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Lanús, Argentina
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Mendoza, Argentina
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Rosario, Argentina
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Burgas, 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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Bogotá, 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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Klaipėda, Lithuania
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Vilnius, Lithuania
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Kuala Lumpur, Malaysia
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Sarawak, Malaysia
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León, Mexico
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México, Mexico
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San Luis Potosí City, 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, 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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Bucharest, 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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Iași, Romania
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Oradea, Romania
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Piteşti, Romania
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Sibiu, Romania
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Târgovişte, Romania
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Târgu Mureş, Romania
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Kazan', Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Kaohsiung Hsien, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Taoyuan Hsien, Taiwan
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Bangkok, Thailand
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Dnipro, 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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Odesa, Ukraine
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Simferopol, Ukraine
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Vinnitsa, Ukraine
Related Publications (1)
Weisler RH, Nolen WA, Neijber A, Hellqvist A, Paulsson B; Trial 144 Study Investigators. Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (Trial 144: a randomized controlled study). J Clin Psychiatry. 2011 Nov;72(11):1452-64. doi: 10.4088/JCP.11m06878.
PMID: 22054050DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca CNS Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 11, 2006
First Posted
April 13, 2006
Study Start
March 1, 2005
Study Completion
July 1, 2007
Last Updated
December 22, 2008
Record last verified: 2008-12