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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Vratsa, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine Fumarate Sustained Release

Drug

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: AMETHYST

Important dates

Study start: 2005
Study completion: 2007
First posted: Jan 19, 2006
Registry last updated: Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed