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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Quetiapine Fumarate Sustained Release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00278941

D1448C00005

Amethyst

Details and patient eligibility

About

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

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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