Phase 3 /Seroquel SR Acute Mania Monotherapy - US

Condition(s) targeted: Affective Psychosis, Bipolar; Manic Disorder; Manic-Depressive Psychosis; Mania; Manic State; 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 Mania for 3 weeks.

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

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

Primary outcome: Change from baseline to final visit in the YMRS total score

Secondary outcome: Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.

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

Criteria:

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.

Research Site, PHOENIX, Arizona, United States

Research Site, LITTLE ROCK, Arkansas, United States

Research Site, CERRITOS, California, United States

Research Site, GARDEN GROVE, 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, SANTA ANA, California, United States

Research Site, TORRANCE, California, United States

Research Site, DENVER, Colorado, United States

Research Site, WASHINGTON, District of Columbia, United States

Research Site, AVENTURA, Florida, United States

Research Site, EAST BRADENTON, Florida, United States

Research Site, HOLLYWOOD, Florida, United States

Research Site, LEESBURG, Florida, United States

Research Site, TAMPA, Florida, United States

Research Sitew, Fort Lauderdale, Florida, United States

Research Site, ATLANTA, Georgia, United States

Research Site, HONOLULU, Hawaii, United States

Research Site, HOFFMAN ESTATES, Illinois, United States

Research Site, NAPERVILLE, Illinois, United States

Research Site, OAK BROOK TERRACE, Illinois, United States

Research Site, GREENWOOD, Indiana, United States

Research Site, INDIANAPOLIS, Indiana, United States

Research Site, WICHITA, Kansas, United States

Research Site, Newton, Kansas, United States

Research Site, LAKE CHARLES, Louisiana, United States

Research Site, NEW ORLEANS, Louisiana, United States

Research Site, SHREVEPORT, Louisiana, United States

Research Site, ROCKVILLE, Maryland, United States

Research Site, ST. LOUIS, Missouri, United States

Research Site, KENILWORTH, New Jersey, United States

Research Site, WILLINGBORO, New Jersey, United States

Research Site, ELMSFORD, New York, United States

Research Site, HOLLISWOOD, New York, United States

Research Site, DURHAM, North Carolina, United States

Research Site, BEACHWOOD, Ohio, United States

Research Site, OKLAHOMA CITY, Oklahoma, United States

Research Site, MOON TOWNSHIP, Pennsylvania, United States

Research Site, PHILADELPHIA, Pennsylvania, United States

Research Site, Charleston, South Carolina, United States

Research Site, MEMPHIS, Tennessee, United States

Research Site, NASHVILLE, Tennessee, United States

Research Site, AUSTIN, Texas, United States

Research Site, DESOTO, Texas, United States

Research Site, HOUSTON, Texas, United States

Research Site, IRVING, Texas, United States

Research Site, SAN ANTONIO, Texas, United States

Research Site, ARLINGTON, Virginia, United States

Research Site, RICHMOND, Virginia, United States

Research Site, BELLEVUE, Washington, United States

Starting date: January 2007
Ending date: September 2007
Last updated: November 2, 2007