Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, MDD
Brief summary
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.
Interventions
DRUGQuetiapine SR
DRUGEscitalopram
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo | — |
Countries
Canada, China, Finland, Malaysia, Mexico, Philippines, South Africa, South Korea, Spain
Outcome results
None listed