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The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seroquel SR | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more | from randomisation to any visit |
| Measure | Description | Time Frame |
|---|---|---|
| The change in PANSS total score | from randomization to week 6 | |
| The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively | from randomization to week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Seroquel Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
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| The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4 | at week 6 |
| Anaheim |
| California |
| United States |
| Research Site | Cerritos | California | United States |
| Research Site | Garden Grove | California | United States |
| Research Site | National City | California | United States |
| Research Site | Pasadena | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Santa Ana | California | United States |
| Research Site | North Miami | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Hoffman Estates | Illinois | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Jackson | Mississippi | United States |
| Research Site | Clementon | New Jersey | United States |
| Research Site | Staten Island | New York | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | QLD | Australia |
| Research Site | Burgas | Bulgaria |
| Research Site | Radnevo | Bulgaria |
| Research Site | Varna | Bulgaria |
| Research Site | Vancouver | British Columbia | Canada |
| Research Site | Aurora | Ontario | Canada |
| Research Site | Burlington | Ontario | Canada |
| Research Site | Mississauga | Ontario | Canada |
| Research Site | Orléans | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Québec | Quebec | Canada |
| Research Site | Sherbrooke | Quebec | Canada |
| Research Site | Prince Albert | Saskatchewan | Canada |
| Research Site | Põltsamaa | Estonia |
| Research Site | Tallinn | Estonia |
| Research Site | Tartu | Estonia |
| Research Site | Helsinki | Finland |
| Research Site | Mikkeli | Finland |
| Research Site | Turku | Finland |
| Research Site | München | Bavaria | Germany |
| Research Site | Göttingen | Lower Saxony | Germany |
| Research Center | Aachen | North Rhine-Westphalia | Germany |
| Research Site | Aachen | North Rhine-Westphalia | Germany |
| Research Site | Jena | Thuringia | Germany |
| Research Site | Halle | Germany |
| Research Site | Marburg | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Debrecen | Hungary |
| Research Site | Gyula | Hungary |
| Research Site | Nagykálló | Hungary |
| Research Site | Szeged | Hungary |
| Research Site | Székesfehérvár | Hungary |
| Research Site | Bologna | BO | Italy |
| Research Site | Cagliari | CA | Italy |
| Research Site | Città di Castello | PG | Italy |
| Research Site | Ellera Di Corciano | PG | Italy |
| Research Site | Torino | TO | Italy |
| Research Site | Bassano del Grappa | VI | Italy |
| Research Site | Quartu Sant'Elena | CA | Italy |
| Research Site | Riga | Latvia |
| Research Site | Sigulda | Latvia |
| Research Site | Ziegzdrai | Kaunas County | Lithuania |
| Research Site | Klapeda | Lithuania |
| Research Site | Šiauliai | Lithuania |
| Research Sitte | Vilnius | Lithuania |
| Research Site | Jerez de la Frontera | Cádiz | Spain |
| Research Site | Alcobendas | Madrid | Spain |
| Research Site | Colmenar Viejo | Madrid | Spain |
| Research Site | Madrid | Madrid | Spain |
| Research Site | Móstoles | Madrid | Spain |
| Research Site | Villamartín | Spain |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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