Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

February 28, 2011

Study Completion Date

February 28, 2011

Conditions
Bipolar DisorderBipolar Depression
Interventions
DRUG

Extended release quetiapine (quetiapine XR)

"Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.~Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study."

DRUG

Sertraline

"Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.~Sertraline titration: 50 mg on day 1-3, 100 mg on day 4, and flexible doses of 50 to 200 mg/d from day 5 to the end of the study."

DRUG

adequate mood stabilizer

An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively).

Trial Locations (4)

Unknown

Research Site, Vitoria-Gasteiz

Research Site, Santander

Research Site, Zamora

Research Site, Vigo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY