Status:

COMPLETED

Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders

Lead Sponsor:

AstraZeneca

Conditions:

Major Depressive Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief 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...

Eligibility Criteria

Inclusion

  • Patient is able to provide written informed consent before beginning any study related procedures
  • Patient has a documented clinical diagnosis of major depressive disorder
  • Patient is able to understand and comply with the requirements of the study, as judged by a study investigator

Exclusion

  • Patients with a history of non-compliance as judged by the study investigator
  • Patients with a known lack of response to previous treatment with quetiapine
  • Patients who have participated in a clinical trial within 4 weeks of randomization

Key Trial Info

Start Date :

April 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2007

Estimated Enrollment :

310 Patients enrolled

Trial Details

Trial ID

NCT00326144

Start Date

April 1 2006

End Date

May 1 2007

Last Update

March 25 2009

Active Locations (34)

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Page 1 of 9 (34 locations)

1

Research Site

Phoenix, Arizona, United States

2

Research Site

Little Rock, Arkansas, United States

3

Research Site

Anaheim, California, United States

4

Research Site

El Centro, California, United States