Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00857584 | Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy | PHASE3 | COMPLETED | 27 | — | — | May 1, 2009 | Feb 1, 2011 | Apr 18, 2012 | 4 | Spain |
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
| Arm | Type | Description |
|---|---|---|
| Quetiapine Extended Release | EXPERIMENTAL | Lithium or valproate at stable doses within seric therapeutic levels |
| Sertraline | ACTIVE_COMPARATOR | Lithium or valproate at stable doses within seric therapeutic levels |
| Name | Type | Description |
|---|---|---|
| Extended release quetiapine (quetiapine XR) | DRUG | 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 | DRUG | 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 | DRUG | 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). |
Inclusion Criteria: * Adult ambulatory patients diagnosed of bipolar disorder I or II, current depressive episode (DSM-IV-TR 4ª Ed: 296.5x or 296.89 codes) * Have been treated with only one mood stabilizer (lithium or valproate) in optimal and stable doses during at least the previous 4 weeks to ra...