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

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ClinicalTrials.gov Identifier: NCT00278941
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Quetiapine Fumarate Sustained Release Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Measures :
  1. Evaluate quetiapine SR compared to placebo on health related quality of life.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278941


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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00278941     History of Changes
Other Study ID Numbers: D1448C00005
Amethyst
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Seroquel SR™
Major Depressive Disorder

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs