CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed
Drug / intervention
Quetiapine Fumarate Sustained Releasedrug
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.

Search/NCT00278941
NCT00278941Phase 3Completed
CompareCT.gov

A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR™) As Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder

AstraZeneca·interventional·Posted Jan 19, 2006·Updated Mar 25, 2009

In Brief

A Phase 3 clinical trial evaluating Quetiapine Fumarate Sustained Release for Major Depressive Disorder. Completed, across 168 sites in 8 countries.

Detailed Summary

The purpose of this study is to determine safety \& efficacy of SEROQUEL SR™ in the treatment of major depressive disorder compared to placebo \& to evaluate quality of sleep, overall quality of life, and effect, if any, on anxiety and satisfaction 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
CountriesBulgaria, Canada, Puerto Rico, Romania, Russia, Slovakia, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 19, 2006
Enrollment StartDec 1, 2005
Study CompletionAug 1, 2007
TodayJul 2, 2026
Posted 20.5 years ago

Interventions

Quetiapine Fumarate Sustained Releasedrug