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

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.

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

Conditions

Major Depressive Disorder

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome 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 Outcome Measures:

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

Study Start

September 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 65 Years
• Genders Eligible for Study: Both

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

Total Enrolment

450

Contact Details

Australian Locations:

• Brisbane, Queensland, Australia
• Everton Park, Queensland, Australia
• Southport, Queensland, Australia
• Frankston, Victoria, Australia
• Malvern, Victoria, Australia
• Prahran, Victoria, Australia
• Richmond, Victoria, Australia

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