Phase III/Seroquel SR Bipolar Depression Monotherapy - US

Completed · Phase 3

Conditions studied: Affective Psychosis, Bipolar, Depression, Bipolar, Manic-Depressive Psychosis, 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 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.

Key facts

Study ID

NCT00422214

Run by

AstraZeneca

People needed

400

Starts

2006-12-01

Expected to finish

2007-06-01

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 1 disorder or Bipolar 11 disorder
• Outpatient status at enrollment

You may not qualify if…

• 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.

Where it is running

• 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 D.C., 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 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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