27
Participants
Start Date
May 31, 2009
Primary Completion Date
February 28, 2011
Study Completion Date
February 28, 2011
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."
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."
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).
Research Site, Vitoria-Gasteiz
Research Site, Santander
Research Site, Zamora
Research Site, Vigo
Lead Sponsor
AstraZeneca
INDUSTRY