Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder

Condition(s) targeted: Major Depressive Disorder

Intervention: Quetiapine Fumarate Sustained Release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

The purpose of this study is to determine safety & efficacy of SEROQUEL SR™ in the treatment of major depressive disorder compared to placebo & to evaluate quality of sleep, overall quality of life, and effect, if any, on anxiety and satisfaction

Official title: A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR™) As Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD)

Secondary outcome: Evaluate quetiapine SR compared to placebo on health related quality of life.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical

Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296. 2x Major Depressive Disorder,

- Single Episode, or 296. 3x Major Depressive Disorder,

Exclusion Criteria:

- Patients with a DSM-IV Axis I disorder other than MDD w/in 6 months of enrollment,

- Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the

patients current psychiatric status.

- Patients whose current episode of depression>12 months or <4 weeks from enrollment

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AstraZeneca Clinical Trial Information - Outside US

Starting date: December 2005
Ending date: September 2007
Last updated: November 2, 2007