Who is sponsoring NCT00388973?

NCT00388973 is sponsored by AstraZeneca.

What condition does NCT00388973 study?

NCT00388973 studies Major Depressive Disorder.

What is the status of NCT00388973?

NCT00388973 is currently COMPLETED.

Last reviewed 2010-03-22 · How we verify

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

NCT00388973 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	COMPLETED
Enrolment	338
Start date	2006-09
Completion	2007-12

Conditions

Major Depressive Disorder

Interventions

Quetiapine

Primary outcomes

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9. — Baseline to Week 9
MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.

Countries

United States, Argentina, Estonia, Finland, Russia, Ukraine