Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder

Condition(s) targeted: Major Depressive Disorder

Intervention: Quetiapine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Catherine Datto, MD, Study Director, Affiliation: AstraZeneca

Overall contact:
AstraZeneca Clinical Study Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com

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 elderly patients with major depressive disorder.

Official title: 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

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary objective of this study is to evaluate the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from randomisation to the end of the treatment (Day 64).

Secondary outcome: The secondary objectives are to evaluate the changes (e.g. in health-related quality of life, anxiety symptoms and sleep quality) by different questionnaires, from randomisation to the end of the treatment (Day 64).

Minimum age: 66 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female patients, 66 years or older, with a documented clinical diagnosis of MDD.

Exclusion Criteria:

- The presence of dementia or other mental disorder than MDD within 6 months of enrolment,

- Uncontrolled hypertension, substance or alcohol abuse

- A current diagnosis of cancer or a current or past diagnosis of stroke

AstraZeneca Clinical Study Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com

Research Site, Birmingham, Alabama, United States; Recruiting

Research Site, City Bell, Buenos Aires, Argentina; Recruiting

Research Site, La Plata, Buenos Aires, Argentina; Recruiting

Research Site, San Diego, California, United States; Recruiting

Research Site, Ft Myers, Florida, United States; Not yet recruiting

Research Site, Sarasota, Florida, United States; Not yet recruiting

Research Site, Gainsville, Florida, United States; Recruiting

Research Site, Roswell, Georgia, United States; Not yet recruiting

Research Site, Vinnitsa, Ukraine; Recruiting

Research Site, SEINÄJOKI, Finland; Recruiting

Research Site, Capital Federal, Argentina; Recruiting

Research Site, Lugansk, Ukraine; Recruiting

Research Site, Mendoza, Argentina; Recruiting

Research Site, Nizhiy Novgorod, Russian Federation; Recruiting

Research Site, BUENOS AIRES, Argentina; Recruiting

Research Site, Donetsk, Ukraine; Recruiting

Research Site, Arkhangelsk, Russian Federation; Recruiting

Research Site, Glevakha, Ukraine; Recruiting

Research Site, SALO, Finland; Recruiting

Research Site, Stavropol, Russian Federation; Recruiting

Research Site, TARTU, Estonia; Recruiting

Research Site, Moscow, Russian Federation; Recruiting

Research Site, OULU, Finland; Not yet recruiting

Research Site, VILJANDI, Estonia; Recruiting

Research Site, Lipetsk, Russian Federation; Recruiting

Research Site, KIEV, Ukraine; Recruiting

Research Site, HELSINKI, Finland; Recruiting

Research Site, St-Petersburg, Russian Federation; Recruiting

Research Site, Dnepropetrovsk, Ukraine; Recruiting

Research Site, Odessa, Ukraine; Recruiting

Research Site, TAMPERE, Finland; Recruiting

Research Site, TALLINN, Estonia; Recruiting

Research Site, JÄRVENPÄÄ, Finland; Not yet recruiting

Research Site, IZHEVSK, Russian Federation; Recruiting

Research Site, Cordoba, Argentina; Recruiting

Research Site, Perm, Russian Federation; Not yet recruiting

Research Site, Dnipropetrovsk, Ukraine; Recruiting

Research Site, KUOPIO, Finland; Recruiting

Research Site, Boston, Massachusetts, United States; Recruiting

Research Site, Brooklyn, New York, United States; Not yet recruiting

Research Site, Avon Lake, Ohio, United States; Not yet recruiting

Research Site, Eugene, Oregon, United States; Recruiting

Research Site, Jenkintown, Pennsylvania, United States; Not yet recruiting

Research Site, Memphis, Tennessee, United States; Recruiting

Research Site, Houston, Texas, United States; Not yet recruiting

Research Site, Austin, Texas, United States; Recruiting

Research Site, San Antonio, Texas, United States; Recruiting

AstraZeneca Clinical Trial Information – Outside US

Starting date: September 2006
Last updated: June 28, 2007