Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients With Major Depressive Disorder
2 other identifiers
interventional
338
6 countries
43
Brief Summary
The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve depressive symptoms in elderly patients with 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started Sep 2006
Shorter than P25 for phase_3 major-depressive-disorder
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 16, 2006
CompletedFirst Posted
Study publicly available on registry
October 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
April 1, 2010
CompletedApril 1, 2010
March 1, 2010
1.2 years
October 16, 2006
December 29, 2008
March 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.
MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.
Baseline to Week 9
Secondary Outcomes (7)
Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)
Baseline to Week 9
Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)
Baseline to Week 9
Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)
Baseline to Week 9
Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index
Baseline to Week 9
Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10
Baseline to Week 9
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients, 66 years or older, with a documented clinical diagnosis of MDD.
You may not qualify if:
- The presence of dementia or mental disorder other than MDD within 6 months of enrolment,
- Uncontrolled hypertension, substance or alcohol abuse
- A current diagnosis of cancer or a current or past diagnosis of stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (43)
Research Site
Birmingham, Alabama, United States
Research Site
San Diego, California, United States
Research Site
Fort Myers, Florida, United States
Research Site
Gainsville, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Roswell, Georgia, United States
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Boston, Massachusetts, United States
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Brooklyn, New York, United States
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Eugene, Oregon, United States
Research Site
Jenkintown, Pennsylvania, United States
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Memphis, Tennessee, United States
Research Site
Austin, Texas, United States
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San Antonio, Texas, United States
Research Site
City Bell, Buenos Aires, Argentina
Research Site
La Plata, Buenos Aires, Argentina
Research Site
Córdoba, Córdoba Province, Argentina
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Mendoza, Mendoza Province, Argentina
Research Site
Buenos Aires, Argentina
Research Site
Capital Federal, Argentina
Research Site
Tartu, Estonia, Estonia
Research Site
Tallinn, Estonia
Research Site
Viljandi, Estonia
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Helsinki, Finland, Finland
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Tampere, Finland, Finland
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Jarvenpaa, Finland
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Kuopio, Finland
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Salo, Finland
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Seinäjoki, Finland
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Arkhangelsk, Russia
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Izhevsk, Russia
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Lipetsk, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
Research Site
Perm, Russia
Research Site
Saint Petersburg, Russia
Research Site
Stavropol, Russia
Research Site
Hlevakha, Kyiv Oblast, Ukraine
Research Site
Dnipropetrovsk, Ukraine
Research Site
Donetsk, Ukraine
Research Site
Kiev, Ukraine
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Luhansk, Ukraine
Research Site
Odesa, Ukraine
Research Site
Vinnitsa, Ukraine
Related Publications (5)
Weisler R, Montgomery SA, Earley WR, Szamosi J, Eriksson H. Extended release quetiapine fumarate in patients with major depressive disorder: suicidality data from acute and maintenance studies. J Clin Psychiatry. 2014 May;75(5):520-7. doi: 10.4088/JCP.13m08624.
PMID: 24816198DERIVEDWeisler R, McIntyre RS. The role of extended-release quetiapine fumarate monotherapy in the treatment of patients with major depressive disorder. Expert Rev Neurother. 2013 Nov;13(11):1161-82. doi: 10.1586/14737175.2013.846520.
PMID: 24175720DERIVEDMontgomery SA, Altamura AC, Katila H, Datto C, Szamosi J, Eriksson H. Efficacy of extended release quetiapine fumarate monotherapy in elderly patients with major depressive disorder: secondary analyses in subgroups of patients according to baseline anxiety, sleep disturbance, and pain levels. Int Clin Psychopharmacol. 2014 Mar;29(2):93-105. doi: 10.1097/YIC.0000000000000007.
PMID: 24162081DERIVEDLocklear JC, Svedsater H, Datto C, Endicott J. Effects of once-daily extended release quetiapine fumarate (quetiapine XR) on quality of life and sleep in elderly patients with major depressive disorder. J Affect Disord. 2013 Jul;149(1-3):189-95. doi: 10.1016/j.jad.2013.01.021. Epub 2013 Apr 29.
PMID: 23639212DERIVEDKatila H, Mezhebovsky I, Mulroy A, Berggren L, Eriksson H, Earley W, Datto C. Randomized, double-blind study of the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder. Am J Geriatr Psychiatry. 2013 Aug;21(8):769-84. doi: 10.1016/j.jagp.2013.01.010. Epub 2013 Feb 6.
PMID: 23567397DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Science Director, Seroquel
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Catherine Datto, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2006
First Posted
October 17, 2006
Study Start
September 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
April 1, 2010
Results First Posted
April 1, 2010
Record last verified: 2010-03