Phase 3 /Seroquel SR Acute Mania Monotherapy - US

Completed · Phase 3

Conditions studied: Affective Psychosis, Bipolar, Manic Disorder, Manic-Depressive Psychosis, Mania, Manic State, Psychoses, Manic-Depressive

In brief

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.

Key facts

Study ID

NCT00422123

Run by

AstraZeneca

People needed

447

Starts

2007-01-01

Expected to finish

2007-07-01

Last updated by the study team

2009-03-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• >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.

Where it is running

• 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
• 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 — Beachwood, Ohio, United States

Full record on ClinicalTrials.gov

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