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

Condition(s) targeted: Major Depressive Disorder

Intervention: Quetiapine (Drug); Amitriptyline (Drug); Bupropion (Drug); Citalopram (Drug); Duloxetine (Drug); Escitalopram (Drug); Fluoxetine (Drug); Paroxetine (Drug); Sertraline (Drug); Venlafaxine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in 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 SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

To evaluate the efficacy of quetiapine fumarate sustained release

(Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.

Secondary outcome: If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.

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, Brisbane, Australia

Research Site, Assebroek, Belgium

Research Site, Brussels, Belgium

Research Site, Gent, Belgium

Research Site, Kortrijk, Belgium

Research Site, Liege, Belgium

Research Site, MECHELEN, Belgium

Research Site, TIELT, Belgium

Research Site, Olomouc, Czech Republic

Research Site, Brno, Czech Republic

Research Site, Havirov, Czech Republic

Research Site, Havlickuv Brod, Czech Republic

Research Site, Nove Mesto nad Metuji, Czech Republic

Research Site, Ostrava, Czech Republic

Research Site, Praha 10, Czech Republic

Research Site, Praha 5, Czech Republic

Research Site, Praha 8, Czech Republic

Research Site, Helsinki, Finland

Research Site, Jarvenpaa, Finland

Research Site, Salo, Finland

Research Site, Turku, Finland

Research Site, Angouleme, France

Research Site, Arcachon, France

Research Site, Caen, France

Research Site, Chateau Gontier, France

Research Site, Elancourt, France

Research Site, Le Pecq, France

Research Site, Nimes, France

Research Site, Paris, France

Research Site, Rennes, France

Research Site, Toulouse, France

Research Site, Augsburg, Germany

Research Site, Berlin, Germany

Research Site, Koln, Germany

Research Site, Munster, Germany

Research Site, Bergen, Norway

Research Site, Flekkefjord, Norway

Research Site, Fyllingsdalen, Norway

Research Site, Hamar, Norway

Research Site, Lysaker, Norway

Research Site, Oslo, Norway

Research Site, SKIEN, Norway

Research Site, Gdansk, Poland

Research Site, Nowy Targ, Poland

Research Site, Lodz, Poland

Research Site, Szczecin, Poland

Research Site, Torun, Poland

Research Site, Warszawa, Poland

Research Site, BUCHAREST, Romania

Research Site, PITESTI, Romania

Research Site, Falkoping, Sweden

Research Site, Halmstad, Sweden

Research Site, GÖTEBORG, Sweden

Research Site, Malmo, Sweden

Research Site, Stockholm, Sweden

Research Site, Sundsvall, Sweden

Research Site, Trollhattan, Sweden

Research Site, Uppsala, Sweden

Research Site, EDMONTON, Alberta, Canada

Research Site, Pretoria, Gauteng, South Africa

Research Site, Durban, Kwazulu-Natal, South Africa

Research Site, MONCTON, New Brunswick, Canada

Research Site, MOUNT PEARL, Newfoundland and Labrador, Canada

Research Site, ST. JOHN'S, Newfoundland and Labrador, Canada

Research Site, HALIFAX, Nova Scotia, Canada

Research Site, TORONTO, Ontario, Canada

Research Site, POINTE-CLAIRE, Quebec, Canada

Research Site, Everton Park, Queensland, Australia

Research Site, Southport, Queensland, Australia

Research Site, Frankston, Victoria, Australia

Research Site, Malvern, Victoria, Australia

Research Site, Prahran, Victoria, Australia

Research Site, Richmond, Victoria, Australia

Research Site, Cape Town, Western Cape, South Africa

AstraZeneca Clinical Trial Information - Outside US

Starting date: September 2005
Ending date: April 2007
Last updated: December 13, 2007