Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression

PHASE3CompletedINTERVENTIONAL
Enrollment

361

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Bipolar Depression
Interventions
DRUG

Quetiapine Fumarate (SEROQUEL) Extended Release

Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.

DRUG

Placebo

Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.

Trial Locations (12)

Unknown

Research Site, Baoding

Research Site, Beijing

Research Site, Changsha

Research Site, Guangzhou

Research Site, Hangzhou

Research Site, Kunming

Research Site, Nanjing

Research Site, Shanghai

Research Site, Shanxi

Research Site, Tianjin

Research Site, Wuhan

Research Site, Xi'an

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY