At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 450 target
Drug / intervention
Quetiapine SR +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Quetiapine SR and Escitalopram for Major Depressive Disorder. Completed, enrolled 450 participants across 42 sites in 9 countries.
Detailed Summary
To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesCanada, China, Finland, Malaysia, Mexico, Philippines, South Africa, South Korea, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedJul 2006
Study CompletionJun 2007
TodayJul 2026
First PostedJul 12, 2006
Enrollment StartMay 1, 2006
Study CompletionJun 1, 2007
TodayJul 2, 2026
Posted 20.0 years ago
Interventions
Quetiapine SRdrug
Escitalopramdrug