At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 494 enrolled
Drug / intervention
Quetiapine +9 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 Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment
In Brief
A Phase 3 clinical trial evaluating Quetiapine, Amitriptyline, and 8 other interventions for Major Depressive Disorder. Completed, enrolled 494 participants across 72 sites in 12 countries.
Detailed Summary
To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with 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
CountriesAustralia, Belgium, Canada, Czechia, Finland, France, Germany, Norway, Poland, Romania, South Africa, Sweden
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedJul 2006
Study CompletionApr 2007
TodayJul 2026
First PostedJul 13, 2006
Enrollment StartMay 1, 2006
Study CompletionApr 1, 2007
TodayJul 2, 2026
Posted 20.0 years ago
Interventions
Quetiapinedrug
Amitriptylinedrug
Bupropiondrug
Citalopramdrug
Duloxetinedrug
Escitalopramdrug
Fluoxetinedrug
Paroxetinedrug
Sertralinedrug
Venlafaxinedrug