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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Escitalopram; Drug: Quetiapine SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00351169

AMBER

D1448C00004

EUDRACT No: 2005-005052-40

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind