Major Depressive Disorder
Conditions
Keywords
MDD, Depression
Brief summary
The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders 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 fumarate
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient is able to provide written informed consent before beginning any study related procedures * Patient has a documented clinical diagnosis of major depressive disorder * Patient is able to understand and comply with the requirements of the study, as judged by a study investigator
Exclusion criteria
* Patients with a history of non-compliance as judged by the study investigator * Patients with a known lack of response to previous treatment with quetiapine * Patients who have participated in a clinical trial within 4 weeks of randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo | — |
| To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo | — |
Countries
United States
Outcome results
None listed