Depression Clinical Trial
— EMBOLDEN IIOfficial title:
Multicentre, Double-blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)
| Verified date | January 2013 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 676 |
| Est. completion date | May 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Male and female out-patients aged 18 to 65 years inclusive - Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed Exclusion Criteria: - Current period of depression lasting less than 4 weeks or more than 12 months - Use of prohibited medication - Substance or alcohol dependence or abuse - Current suicide risk or suicide attempt within 6 months - Breast feeding or pregnancy - Clinically relevant disease or clinical finding |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Research Site | Brisbane | Queensland |
| Australia | Research Site | Epping | Victoria |
| Australia | Research Site | Everton Park | Queensland |
| Australia | Research Site | Malvern | Victoria |
| Australia | Research Site | Southport | Queensland |
| Chile | Research Site | Providencia Santiago | |
| Chile | Research Site | Santiago | |
| Colombia | Research Site | Bogota | |
| Costa Rica | Research Site | San Jose | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Thessaloniki | |
| Greece | Research Site | Tripoli | |
| Mexico | Research Site | Mexico | |
| Mexico | Research Site | Yucatan | |
| Peru | Research Site | Lima | |
| Peru | Research Site | San Borja | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Galati | |
| Romania | Research Site | Iasi | |
| Romania | Research Site | Magura | |
| South Africa | Research Site | Benoni | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Durban | |
| South Africa | Research Site | Pretoria | |
| Turkey | Research Site | Gaziantep | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Manisa | |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Bellevue | Washington |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clementon | New Jersey |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Glen Burnie | Maryland |
| United States | Research Site | Irving | Texas |
| United States | Research Site | Kirkland | Washington |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Maitland | Florida |
| United States | Research Site | National City | California |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New York | New York |
| United States | Research Site | Northfield | Illinois |
| United States | Research Site | Oak Brook | Illinois |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | San Clemente | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Smyrna | Georgia |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Australia, Chile, Colombia, Costa Rica, Greece, Mexico, Peru, Romania, South Africa, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS) | |||
| Secondary | Secondary variables supportive to the primary objective: | |||
| Secondary | MADRS total score response | |||
| Secondary | MADRS total score remission |
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