To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA...
Date First Received: July 11, 2006
Last Updated: December 18, 2008
Verified by: AstraZeneca, December 2007
Clinical Trial Phase: Phase 3 | Start Date: May 2006
Overall Status: Completed
Estimated Enrollment: 450
Brief Summary
Official Title: “A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder”
Condition Keyword(s):
Intervention(s):
To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder.
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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Quetiapine SR
- Drug: Escitalopram
Outcome Measures for this Clinical Trial
Primary Measures
- To evaluate the efficacy of quetiapine SR compared with placebo in the treatment of patients with major depressive disorder (MDD) as assessed by change from randomisation to week 8 score in the MADRS total score.
Secondary Measures
- If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Male or female aged 18 to 65 years
- A documented diagnosis of major depressive disorder
Exclusion Criteria:
- Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment
- Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status
- Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment
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 Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Willie Earley, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00351169
Study ID Number: D1448C00004
ClinicalTrials.gov Identifier: NCT00351169
Health Authority: Mexico: National Institute of Public Health, Health Secretariat
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
