Seroquel in Bipolar Depression Versus Lithium
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.
Drug: Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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)|
- The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
- MADRS total score response
- MADRS total score remission
|Study Start Date:||August 2005|
|Study Completion Date:||May 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206141
Show 76 Study Locations
|Study Director:||AstraZeneca Seroquel Medical Science Director, MD||AstraZeneca|