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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Quetiapine
• Drug: Amitriptyline
• Drug: Bupropion
• Drug: Citalopram
• Drug: Duloxetine
• Drug: Escitalopram
• Drug: Fluoxetine
• Drug: Paroxetine
• Drug: Sertraline
• Drug: Venlafaxine

Primary Measures

• 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 Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Seroquel Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00351910

Study ID Number: D1448C00007

ClinicalTrials.gov Identifier: NCT00351910

Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

AstraZeneca Clinical Trial Information - Outside US