Mania Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania
| Verified date | March 2009 |
| 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 the safety and efficacy of sustained-release
quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3
weeks.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
was changed to XR after consultation with FDA.
| Status | Completed |
| Enrollment | 447 |
| Est. completion date | July 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Provision of written informed consent - Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed - Inpatient hospital admission for the first 4 days of study treatment Exclusion Criteria: - >8 mood episodes within the last 12 months - Use of prohibited medication - Substance or alcohol abuse or dependence - Current suicide risk or suicide attempt within last 6 months. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Arlington | Virginia |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Aventura | Florida |
| United States | Research Site | Beachwood | Ohio |
| United States | Research Site | Bellevue | Washington |
| United States | Research Site | Cerritos | California |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Desoto | Texas |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | East Bradenton | Florida |
| United States | Research Site | Elmsford | New York |
| United States | Research Sitew | Fort Lauderdale | Florida |
| United States | Research Site | Garden Grove | California |
| United States | Research Site | Greenwood | Indiana |
| United States | Research Site | Hoffman Estates | Illinois |
| United States | Research Site | Holliswood | New York |
| United States | Research Site | Hollywood | Florida |
| United States | Research Site | Honolulu | Hawaii |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Irving | Texas |
| United States | Research Site | Kenilworth | New Jersey |
| United States | Research Site | Lake Charles | Louisiana |
| United States | Research Site | Leesburg | Florida |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Moon Township | Pennsylvania |
| United States | Research Site | Naperville | Illinois |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | Newton | Kansas |
| United States | Research Site | Oak Brook Terrace | Illinois |
| United States | Research Site | Oceanside | California |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Pico Rivera | California |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rockville | Maryland |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Santa Ana | California |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Torrance | California |
| United States | Research Site | Washington | District of Columbia |
| United States | Research Site | Wichita | Kansas |
| United States | Research Site | Willingboro | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline to final visit in the YMRS total score | |||
| Secondary | Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS. |
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