Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

Condition(s) targeted: Major Depressive Disorder

Intervention: Quetiapine SR (Drug); Escitalopram (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

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

To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder.

Official title: A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder

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

Primary outcome: To evaluate the efficacy of quetiapine SR compared with placebo in the treatment of patients with major depressive disorder (MDD) as assessed by change from randomisation to week 8 score in the MADRS total score.

Secondary outcome: If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female aged 18 to 65 years

- A documented diagnosis of major depressive disorder

Exclusion Criteria:

- Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment

- Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the

patient's current psychiatric status

- Patients whose current episode of depression exceeds 12 months or is less than 4 weeks

prior to enrolment

Research Site, WU HAN, China

Research Site, BEIJING, China

Research Site, HA ERBING, China

Research Site, NANJING, China

Research Site, SHANGHAI, China

Research Site, Helsinki, Finland

Research Site, Oulu, Finland

Research Site, Tampere, Finland

Research Site, Turku, Finland

Research Site, Seoul, Korea, Republic of

Research Site, Johor Bahru, Malaysia

Research Site, Perak, Malaysia

Research Site, Petaling Jaya, Malaysia

Research Site, Aguascalientes, Mexico

Research Site, Distrito Federal, Mexico

Research Site, Guadalajara, Mexico

Research Site, Cebu City, Philippines

Research Site, Mandaluyong City, Philippines

Research Site, Manila, Philippines

Research Site, Davao City, Philippines

Research Site, Krugersdorp, South Africa

Research Site, Benoni, South Africa

Research Site, Cape Town, South Africa

Research Site, JOHANNESBURG, South Africa

Research Site, DURBAN, South Africa

Research Site, Sama de Langreo, Spain

Research Site, Zamora, Spain

Research Site, Vigo, Spain

Research Site, EDMONTON, Alberta, Canada

Research Site, Kelowna, British Columbia, Canada

Research Site, Penticton, British Columbia, Canada

Research Site, Vancouver, British Columbia, Canada

Research Site, St. John's, Newfoundland and Labrador, Canada

Research Site, Halifax, Nova Scotia, Canada

Research Site, Sydney, Nova Scotia, Canada

Research Site, Hamilton, Ontario, Canada

Research Site, Ottawa, Ontario, Canada

Research Site, Sudbury, Ontario, Canada

Research Site, Toronto, Ontario, Canada

Research Site, Oakville, Ontario, Canada

Research Site, Montreal, Quebec, Canada

Research Site, GATINEAU, Quebec, Canada

AstraZeneca Clinical Trial Information - Outside US

Starting date: May 2006
Ending date: June 2007
Last updated: December 13, 2007