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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT 2004-000915-25 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine fumarate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to recurrence of a mood event |
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to recurrence of a manic event | ||
| Time from randomization to recurrence of a depressed event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca CNS Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cerritos | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22054050 | Derived | 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. |
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| San Diego |
| California |
| United States |
| Research Site | Santa Ana | California | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Gainesville | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | North Miami | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Eagle | Idaho | United States |
| Research Site | Hoffman Estates | Illinois | United States |
| Research Site | Terre Haute | Indiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Flowood | Mississippi | United States |
| Research Site | Saint Charles | Missouri | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Clementon | New Jersey | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Fargo | North Dakota | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Salem | Oregon | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Lake Jackson | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Bellevue | Washington | United States |
| Research Site | Kirkland | Washington | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Capital Federal | Argentina |
| Research Site | Córdoba | Argentina |
| Research Site | La Plata | Argentina |
| Research Site | Lanus | Argentina |
| Research Site | Mendoza | Argentina |
| Research Site | Rosario | Argentina |
| Research Site | Burgas | Bulgaria |
| Research Site | Plovdiv | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Antioquia | Colombia |
| Research Site | Barranquilla | Colombia |
| Research Site | Bogotá | Colombia |
| Research Site | Pereira | Colombia |
| Research Site | Ahmedabad | India |
| Research Site | Chennai | India |
| Research Site | Jaipur | India |
| Research Site | Kanpur | India |
| Research Site | Lucknow | India |
| Research Site | Mangalore | India |
| Research Site | Manipal | India |
| Research Site | Mumbai | India |
| Research Site | New Delhi | India |
| Research Site | Visakhapatnam | India |
| Research Site | Kaunas | Lithuania |
| Research Site | Klaipėda | Lithuania |
| Research Site | Vilnius | Lithuania |
| Research Site | Kuala Lumpur | Malaysia |
| Research Site | Sarawak | Malaysia |
| Research Site | León | Mexico |
| Research Site | México | Mexico |
| Research Site | San Luis Potosí City | Mexico |
| Research Site | Lima | Peru |
| Research Site | Cebu City | Philippines |
| Research Site | Davao City | Philippines |
| Research Site | Mandaluyong | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Arad | Romania |
| Research Site | Brasov | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Cluj-Napoca | Romania |
| Research Site | Com Jebel | Romania |
| Research Site | Craiova | Romania |
| Research Site | Iași | Romania |
| Research Site | Oradea | Romania |
| Research Site | Piteşti | Romania |
| Research Site | Sibiu | Romania |
| Research Site | Targoviste | Romania |
| Research Site | Târgu Mureş | Romania |
| Research Site | Kazan' | Russia |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Kaohsiung Hsien | Taiwan |
| Research Site | Taipei | Taiwan |
| Research Site | Taoyuan City | Taiwan |
| Research Site | Taoyuan Hsien | Taiwan |
| Research Site | Bangkok | Thailand |
| Research Site | Dnipro | Ukraine |
| Research Site | Kharkiv | Ukraine |
| Research Site | Kiev | Ukraine |
| Research Site | Kyiv | Ukraine |
| Research Site | Lviv | Ukraine |
| Research Site | Odesa | Ukraine |
| Research Site | Simferopol | Ukraine |
| Research Site | Vinnitsa | Ukraine |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood 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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