CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 450 target
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.

Search/NCT00326105
NCT00326105Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Randomized, 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 (PEARL STUDY)

AstraZeneca·interventional·Posted May 16, 2006·Updated Mar 25, 2009

In Brief

A Phase 3 clinical trial evaluating Quetiapine fumarate for Major Depressive Disorder. Completed, enrolled 450 participants across 56 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in patients with MDD with inadequate response to an antidepressant treatment. 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
First PostedMay 16, 2006
Enrollment StartApr 1, 2006
Study CompletionJul 1, 2007
TodayJul 2, 2026
Posted 20.1 years ago

Interventions

Quetiapine fumaratedrug