Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine fumarate (Seroquel) | Drug | |||
| paroxetine | Drug | |||
| mood stabilizing activity | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary variables supportive to the primary objective: | ||
| MADRS total score response | ||
| MADRS total score remission |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Seroquel Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20122366 | Derived | McElroy SL, Weisler RH, Chang W, Olausson B, Paulsson B, Brecher M, Agambaram V, Merideth C, Nordenhem A, Young AH; EMBOLDEN II (Trial D1447C00134) Investigators. A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry. 2010 Feb;71(2):163-74. doi: 10.4088/JCP.08m04942gre. Epub 2010 Jan 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Little Rock |
| Arkansas |
| United States |
| Research Site | National City | California | United States |
| Research Site | San Clemente | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Maitland | Florida | United States |
| Research Site | Winter Park | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Smyrna | Georgia | United States |
| Research Site | Northfield | Illinois | United States |
| Research Site | Oak Brook | Illinois | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Glen Burnie | Maryland | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Clementon | New Jersey | United States |
| Research Site | New York | New York | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Irving | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Bellevue | Washington | United States |
| Research Site | Kirkland | Washington | United States |
| Research Site | Brisbane | Queensland | Australia |
| Research Site | Everton Park | Queensland | Australia |
| Research Site | Southport | Queensland | Australia |
| Research Site | Epping | Victoria | Australia |
| Research Site | Malvern | Victoria | Australia |
| Research Site | Providencia Santiago | Chile |
| Research Site | Santiago | Chile |
| Research Site | Bogotá | Colombia |
| Research Site | San José | Costa Rica |
| Research Site | Athens | Greece |
| Research Site | Thessaloniki | Greece |
| Research Site | Tripoli | Greece |
| Research Site | México | Mexico |
| Research Site | Yucatán | Mexico |
| Research Site | Lima | Peru |
| Research Site | San Borja | Peru |
| Research Site | Bucharest | Romania |
| Research Site | Galati | Romania |
| Research Site | Iași | Romania |
| Research Site | Măgura | Romania |
| Research Site | Benoni | South Africa |
| Research Site | Cape Town | South Africa |
| Research Site | Durban | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Gaziantep | Turkey (Türkiye) |
| Research Site | Istanbul | Turkey (Türkiye) |
| Research Site | Manisa | Turkey (Türkiye) |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D017374 | Paroxetine |
| 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 |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided