Phase III/Seroquel SR Bipolar Depression Monotherapy - US

Condition(s) targeted: Affective Psychosis, Bipolar; Depression, Bipolar; Manic-Depressive Psychosis; Psychoses, Manic-Depressive

Intervention: Quetiapine fumarate (Seroquel) SR (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Catherine Datto, MD, Study Director, Affiliation: AstraZeneca
Larisa Acevedo, Ph.D, Study Director, Affiliation: AstraZeneca

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in depression symptoms by final visit as measured by the MADRS total score

Secondary outcome: Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Research Site, BIRMINGHAM, Alabama, United States

Research Site, PHOENIX, Arizona, United States

Research Site, SCOTTSDALE, Arizona, United States

Research Site, LITTLE ROCK, Arkansas, United States

Research Site, CERRITOS, California, United States

Research Site, LA MESA, California, United States

Research Site, LOS ANGELES, California, United States

Research Site, NEWPORT BEACH, California, United States

Research Site, NORTHRIDGE, California, United States

Research Site, OCEANSIDE, California, United States

Research Site, PICO RIVERA, California, United States

Research Site, SAN DIEGO, California, United States

Research Site, WILDOMAR, California, United States

Research Site, WASHINGTON, District of Columbia, United States

Research Site, BRADENTON, Florida, United States

Research Site, FORT LAUDERDALE, Florida, United States

Research Site, JACKSONVILLE, Florida, United States

Research Site, LEESBURG, Florida, United States

Research Site, MAITLAND, Florida, United States

Research Site, NORTH MIAMI, Florida, United States

Research Site, ORLANDO, Florida, United States

Research Site, TAMPA, Florida, United States

Research Site, WEST PALM BEACH, Florida, United States

Research Site, SMYRNA, Georgia, United States

Research Site, HONOLULU, Hawaii, United States

Research Site, JOLIET, Illinois, United States

Research Site, GREENWOOD, Indiana, United States

Research Site, INDIANAPOLIS, Indiana, United States

Research Site, WICHITA, Kansas, United States

Research Site, SHREVEPORT, Louisiana, United States

Research Site, ROCKVILLE, Maryland, United States

Research Site, FARMINGTON HILLS, Michigan, United States

Research Site, ST. LOUIS, Missouri, United States

Research Site, CHERRY HILL, New Jersey, United States

Research Site, CLEMENTON, New Jersey, United States

Research Site, BROOKLYN, New York, United States

Research Site, NEW YORK, New York, United States

Research Site, STATEN ISLAND, New York, United States

Research Site, BEACHWOOD, Ohio, United States

Research Site, CINCINNATI, Ohio, United States

Research Site, DAYTON, Ohio, United States

Research Site, OKLAHOMA CITY, Oklahoma, United States

Research Site, PORTLAND, Oregon, United States

Research Site, SALEM, Oregon, United States

Research Site, PHILADELPHIA, Pennsylvania, United States

Research Site, CHARLESTON, South Carolina, United States

Research Site, MEMPHIS, Tennessee, United States

Research Site, DALLAS, Texas, United States

Research Site, HOUSTON, Texas, United States

Research Site, CHARLOTTESVILLE, Virginia, United States

Research Site, VIRGINIA BEACH, Virginia, United States

Research Site, BELLEVUE, Washington, United States

Research Site, SEATTLE, Washington, United States

Research Site, SOUTH KIRKLAND, Washington, United States

Starting date: December 2006
Last updated: November 2, 2007