Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression
NCT ID: NCT00926393
Last Updated: 2011-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
139 participants
INTERVENTIONAL
2009-06-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Quetiapine Immediate Release (IR)
Quetiapine 25, 100, 200 and 300 mg
Quetiapine Immediate Release
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
Quetiapine Extended Release (XR)
Quetiapine 50, 200, 300
Quetiapine Extended Release
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
Interventions
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Quetiapine Immediate Release
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
Quetiapine Extended Release
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Outpatient status as enrollment
Exclusion Criteria
18 Years
50 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Catherine Datto, MD
Role: STUDY_DIRECTOR
AstraZeneca
References
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Riesenberg RA, Baldytcheva I, Datto C. Self-reported sedation profile of quetiapine extended-release and quetiapine immediate-release during 6-day initial dose escalation in bipolar depression: a multicenter, randomized, double-blind, phase IV study. Clin Ther. 2012 Nov;34(11):2202-11. doi: 10.1016/j.clinthera.2012.09.002. Epub 2012 Oct 8.
Other Identifiers
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D1443C00040
Identifier Type: -
Identifier Source: org_study_id
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