drugset / Trial / NCT00119652

Seroquel in Bipolar Depression Versus SSRI

NCT00119652 ↗

Phase 3 Completed 676 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.

Timeline

Start
2005-05
Primary completion
—
Completion
2007-05

Outcome

Met primary endpoint

paper P < .001 for both quetiapine doses, P = .313 for paroxetine, vs placebo). PMID 20122366 ↗

paper Quetiapine (300 or 600 mg/d), but not paroxetine, was more effective than placebo for treating acute depressive episodes in bipolar I and II disorder. PMID 20122366 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Paroxetine Small molecule 20 mg —
Subject Quetiapine Small molecule 300 mg —
Subject Quetiapine Small molecule 600 mg —

Indications