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| ID | Type | Description | Link |
|---|---|---|---|
| EMBOLDEN I |
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This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. |
| Measure | Description | Time Frame |
|---|---|---|
| MADRS total score response | ||
| MADRS total score remission |
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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 | Kelowna | British Columbia | Canada | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20122369 | Derived | Young AH, McElroy SL, Bauer M, Philips N, Chang W, Olausson B, Paulsson B, Brecher M; EMBOLDEN I (Trial 001) Investigators. A double-blind, placebo-controlled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I). J Clin Psychiatry. 2010 Feb;71(2):150-62. doi: 10.4088/JCP.08m04995gre. Epub 2010 Jan 26. |
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| Sydney |
| Nova Scotia |
| Canada |
| Research Site | Greater Sudbury | Ontario | Canada |
| Research Site | Markham | Ontario | Canada |
| Research Site | Mississauga | Ontario | Canada |
| Research Site | Orléans | Ontario | Canada |
| Research Site | Waterloo | Ontario | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Sherbrooke | Quebec | Canada |
| Research Site | Osijek | Croatia |
| Research Site | Split | Croatia |
| Research Site | Zadar | Croatia |
| Research Site | Zagreb-Susedgrad | Croatia |
| Research Site | Kohtla-Järve | Estonia |
| Research Site | Tallinn | Estonia |
| Research Site | Tartu | Estonia |
| Research Site | Berlin | Germany |
| Research Site | Würzburg | Germany |
| Research Site | Solo | Java | Indonesia |
| Research Site | Jakarta | Indonesia |
| Research Site | Lawang | Indonesia |
| Research Site | Daugavpils | Latvia |
| Research Site | Riga | Latvia |
| Research Site | Kaunas | Lithuania |
| Research Site | Šiauliai | Lithuania |
| Research Site | Vilnius | Lithuania |
| Research Site | Kuala Lumpur | Malaysia |
| Research Site | Kuching Sarawak | Malaysia |
| Research Site | Petaling Jaya | Malaysia |
| Research Site | Brattvåg | Norway |
| Research Site | Drammen | Norway |
| Research Site | Fredrikstad | Norway |
| Research Site | Mysen | Norway |
| Research Site | Paradis | Norway |
| Research Site | Davao City | Philippines |
| Research Site | Iloilo City | Philippines |
| Research Site | Mandaluyong | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Bialystok | Poland |
| Research Site | Bydgoszcz | Poland |
| Research Site | Gdynia | Poland |
| Research Site | Leszno | Poland |
| Research Site | Lodz | Poland |
| Research Site | Skorzewo | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Zabrze | Poland |
| Research Site | Arkhangelsk | Russia |
| Research Site | Kazan' | Russia |
| Research Site | Lipetsk | Russia |
| Research Site | Moscow | Russia |
| Research Site | Nizhny Novgorod | Russia |
| Research Site | Rostov-on-Don | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Saratov | Russia |
| Research Site | Smolensk | Russia |
| Research Site | Stavropol | Russia |
| Research Site | Tver' | Russia |
| Research Site | Yaroslavl | Russia |
| Research Site | Belgrade | Serbia |
| Research Site | Čačak | Serbia |
| Research Site | Kragujevac | Serbia |
| Research Site | Niš | Serbia |
| Research Site | Valjevo | Serbia |
| Research Site | Gyeonggi-do | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Changhua | Taiwan |
| Research Site | Taipei | Taiwan |
| Research Site | Dnipropetrovsk | Ukraine |
| Research Site | Donetsk | Ukraine |
| Research Site | Kharkiv | Ukraine |
| Research Site | Kiev | Ukraine |
| Research Site | Luhansk | Ukraine |
| Research Site | Lviv | Ukraine |
| Research Site | Odesa | Ukraine |
| Research Site | Simferopol | Ukraine |
| Research Site | Vinnitsa | Ukraine |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D004364 | Pharmaceutical Preparations |
| 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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