Clinical trial NCT00422214: Phase III/Seroquel SR Bipolar Depression Monotherapy - US
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Affective Psychosis, Bipolar
Depression, Bipolar
Manic-Depressive Psychosis
Psychoses, Manic-Depressive
Keywords: Bipolar Disorder
Bipolar Depression,
Manic Depression
Seroquel
Seroquel SR
quetiapine fumarate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 Depression for 8 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
* Outpatient status at enrollment

Exclusion Criteria:

* Patients with \>8 mood episodes during the past 12 years
* Use of prohibited medications
* Substance or alcohol abuse or dependence
* Current suicide risk or suicide attempt within last 6 months.

Primary outcomes:
measure: Change from baseline in depression symptoms by final visit as measured by the MADRS total score
Secondary outcomes:
measure: Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Cerritos
country: United States
facility: Research Site
state: California
city: La Mesa
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Northridge
country: United States
facility: Research Site
state: California
city: Oceanside
country: United States
facility: Research Site
state: California
city: Pico Rivera
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Wildomar
country: United States
facility: Research Site
state: California
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Bradenton
country: United States
facility: Research Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Leesburg
country: United States
facility: Research Site
state: Florida
city: Maitland
country: United States
facility: Research Site
state: Florida
city: North Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Smyrna
country: United States
facility: Research Site
state: Georgia
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Joliet
country: United States
facility: Research Site
state: Illinois
city: Greenwood
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Rockville
country: United States
facility: Research Site
state: Maryland
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Cherry Hill
country: United States
facility: Research Site
state: New Jersey
city: Clementon
country: United States
facility: Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Beachwood
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Salem
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Virginia Beach
country: United States
facility: Research Site
state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: South Kirkland
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: AstraZeneca
name: Catherine Datto, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Larisa Acevedo, Ph.D
role: STUDY_DIRECTOR
References: