Clinical trial NCT00422123: Phase 3 /Seroquel SR Acute Mania 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®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Affective Psychosis, Bipolar
Manic Disorder
Manic-Depressive Psychosis
Mania
Manic State
Psychoses, Manic-Depressive
Keywords: Bipolar Disorder
Bipolar Mania
Manic Depression
Seroquel
Seroquel SR
quetiapine fumarate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 447
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 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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline to final visit in the YMRS total score
Secondary outcomes:
measure: Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.
Other outcomes:
Locations:
city: Phoenix
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: Garden Grove
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: Santa Ana
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Aventura
country: United States
facility: Research Site
state: Florida
city: East Bradenton
country: United States
facility: Research Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Research Sitew
state: Florida
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Leesburg
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Hoffman Estates
country: United States
facility: Research Site
state: Illinois
city: Naperville
country: United States
facility: Research Site
state: Illinois
city: Oak Brook Terrace
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: Newton
country: United States
facility: Research Site
state: Kansas
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Lake Charles
country: United States
facility: Research Site
state: Louisiana
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Rockville
country: United States
facility: Research Site
state: Maryland
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Kenilworth
country: United States
facility: Research Site
state: New Jersey
city: Willingboro
country: United States
facility: Research Site
state: New Jersey
city: Elmsford
country: United States
facility: Research Site
state: New York
city: Holliswood
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Beachwood
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Moon Township
country: United States
facility: Research Site
state: Pennsylvania
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: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Desoto
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Irving
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Arlington
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Bellevue
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:
citation: Cutler AJ, Datto C, Nordenhem A, Minkwitz M, Acevedo L, Darko D. Extended-release quetiapine as monotherapy for the treatment of adults with acute mania: a randomized, double-blind, 3-week trial. Clin Ther. 2011 Nov;33(11):1643-58. doi: 10.1016/j.clinthera.2011.10.002. Epub 2011 Nov 4.