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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Duloxetine

Drug: Bupropion

Drug: Fluoxetine

Drug: Citalopram

Drug: Paroxetine

Drug: Amitriptyline

Drug: Venlafaxine

Drug: Sertraline

Drug: Escitalopram

Drug: Quetiapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00351910

EUDRACT No: 2005-0055053-22

D1448C00007

ONYX

Details and patient eligibility

About

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.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Enrollment

494 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