Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression

PHASE3CompletedINTERVENTIONAL
Enrollment

421

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Acute Bipolar Depression
Interventions
DRUG

Quetiapine fumarate XR

Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.

DRUG

Lithium carbonate

Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day

Trial Locations (24)

Unknown

Research Site, La Plata

Research Site, Godoy Cruz

Research Site, Mendoza

Research Site, Caba

Research Site, Aparecida de Goiânia

Research Site, Rio de Janeiro

Research Site, São Paulo

Research Site, Santiago

Research Site, Medellín

Research Site, Bogota D.c

Research Site, Guatemala City

Research Site, Monterrey

Research Site, San Luis Potosí City

Research Site, Durango

Research Site, Monterrey

Research Site, Lima

Research Site, Ankara

Research Site, Elâzığ

Research Site, Istanbul

Research Site, Izmir

Research Site, Kocaeli

Research Site, Malatya

Research Site, Manisa

Research Site, Caracas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY