Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
NCT ID: NCT00779506
Last Updated: 2011-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
96 participants
INTERVENTIONAL
2008-11-30
2009-07-31
Brief Summary
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PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Quetiapine Fumarate XR
Seroquel XR 400-800mg
Quetiapine Fumarate XR
oral, once daily, flexible dose
Interventions
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Quetiapine Fumarate XR
oral, once daily, flexible dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PANSS total score of at least 70 at enrolment and at assignment Day 1
* CGI Severity of Illness score of at least 4 (moderately ill) at enrolment and at assignment Day 1 and with worsening of the patient's condition during the 3 weeks
Exclusion Criteria
* Administration of a depot antipsychotic injection within one dosing interval (for the depot) before assignment
* Substance or alcohol dependence at enrolment
* Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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YounHoon Kim
Role: PRINCIPAL_INVESTIGATOR
Inje University
Locations
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Research site
Ansan, Gyeonggi-do, South Korea
Research site
Gwangju, Gyeonggi-do, South Korea
Research site
Bugok, Gyeongsangnam-do, South Korea
Research site
Masan, Gyeongsangnam-do, South Korea
Research site
Incheon, , South Korea
Research site
Pusan, , South Korea
Research site
Seoul, , South Korea
Countries
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Other Identifiers
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D1443L00062
Identifier Type: -
Identifier Source: org_study_id