At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 338 enrolled
Drug / intervention
Quetiapinedrug
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 SR) in the Treatment of Elderly Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Quetiapine for Major Depressive Disorder. Completed, enrolled 338 participants across 43 sites in 6 countries.
Detailed Summary
The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve depressive symptoms in elderly 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
CountriesArgentina, Estonia, Finland, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2006
First PostedOct 2006
Primary CompletionDec 2007
TodayJul 2026
First PostedOct 17, 2006
Enrollment StartSep 1, 2006
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.7 years ago
Interventions
Quetiapinedrug