At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 310 enrolled
Drug / intervention
Quetiapine fumaratedrug
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 Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR®) as Mono-Therapy in the Treatment of Adult Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Quetiapine fumarate for Major Depressive Disorder. Completed, enrolled 310 participants across 34 sites.
Detailed Summary
The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders 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
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedMay 2006
Study CompletionMay 2007
TodayJul 2026
First PostedMay 16, 2006
Enrollment StartApr 1, 2006
Study CompletionMay 1, 2007
TodayJul 2, 2026
Posted 20.1 years ago
Interventions
Quetiapine fumaratedrug