Major Depressive Disorder Clinical Trial
— AMBEROfficial 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
To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR)
in the treatment of 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.
Status | Completed |
Enrollment | 450 |
Est. completion date | June 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Research Site | Edmonton | Alberta |
Canada | Research Site | Gatineau | Quebec |
Canada | Research Site | Halifax | Nova Scotia |
Canada | Research Site | Hamilton | Ontario |
Canada | Research Site | Kelowna | British Columbia |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Oakville | Ontario |
Canada | Research Site | Ottawa | Ontario |
Canada | Research Site | Penticton | British Columbia |
Canada | Research Site | St. John's | Newfoundland and Labrador |
Canada | Research Site | Sudbury | Ontario |
Canada | Research Site | Sydney | Nova Scotia |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Vancouver | British Columbia |
China | Research Site | Beijing | |
China | Research Site | Ha Erbing | |
China | Research Site | Nanjing | |
China | Research Site | Shanghai | |
China | Research Site | Wu Han | |
Finland | Research Site | Helsinki | |
Finland | Research Site | Oulu | |
Finland | Research Site | Tampere | |
Finland | Research Site | Turku | |
Korea, Republic of | Research Site | Seoul | |
Malaysia | Research Site | Johor Bahru | |
Malaysia | Research Site | Perak | |
Malaysia | Research Site | Petaling Jaya | |
Mexico | Research Site | Aguascalientes | |
Mexico | Research Site | Distrito Federal | |
Mexico | Research Site | Guadalajara | |
Philippines | Research Site | Cebu City | |
Philippines | Research Site | Davao City | |
Philippines | Research Site | Mandaluyong City | |
Philippines | Research Site | Manila | |
South Africa | Research Site | Benoni | |
South Africa | Research Site | Cape Town | |
South Africa | Research Site | Durban | |
South Africa | Research Site | Johannesburg | |
South Africa | Research Site | Krugersdorp | |
Spain | Research Site | Sama de Langreo | |
Spain | Research Site | Vigo | |
Spain | Research Site | Zamora |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Canada, China, Finland, Korea, Republic of, Malaysia, Mexico, Philippines, South Africa, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo |
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