NCT00206141

Seroquel in Bipolar Depression Versus Lithium

Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 672 (planned)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.

Conditions

• Bipolar Disorder
• Bipolar Depression
• Depression

Interventions

Type	Name	Description
DRUG	Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)

Timeline

• Start date: 2005-08-01
• Completion: 2007-05-01
• First posted: 2005-09-21
• Last updated: 2013-01-04

Locations

76 sites across 16 countries: Canada, Croatia, Estonia, Germany, Indonesia, Latvia, Lithuania, Malaysia, Norway, Philippines, Poland, Russia, Serbia, South Korea, Taiwan, Ukraine