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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Quetiapine Fumarate Sustained Release
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- Evaluate quetiapine SR compared to placebo on health related quality of life.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
AstraZeneca Seroquel Medical Science Director, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00278941
Study ID Number: D1448C00005
ClinicalTrials.gov Identifier: NCT00278941
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00278941
