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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
338
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.
Time frame: Baseline to Week 9
Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)
Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life.
Time frame: Baseline to Week 9
Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)
Item 15 the Quality of Life, Enjoyment Satisfaction Questionnaire (score 1 least -5 best) on Q-LES-Q, calculated as Week 9 value - baseline value
Time frame: Baseline to Week 9
Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)
Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety.
Time frame: Baseline to Week 9
Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index is an eighteen questionnaire scored with 7 sleep component scores each on a 0 to 3 scale, total score range from 0 to 21, worst value 21, best value 0
Time frame: Baseline to Week 9
Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10
The suicide item is a single item of the Montgomery-Asberg Depression Rating Scale with a range of values from 0 to 6, worst value 6, best value 0
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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
Research Site
Boston, Massachusetts, United States
Research Site
Brooklyn, New York, United States
Research Site
Eugene, Oregon, United States
Research Site
Jenkintown, Pennsylvania, United States
...and 33 more locations
Time frame: Baseline to Week 9
Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)
The Somatic symptom Cluster of the Hamilton Anxiety Scale is a 7 item cluster associated with somatic symptoms \*somatic muscular, somatic sensory, cardiovascular system, respiratory system, gastrointestinal system, genitourinary system, autonomic system) with a range of values from 0 to 28, worst value 28, best value 0
Time frame: Baseline to Week 9
Tolerability as Measured by Adverse Event Withdrawals During Treatment
Time frame: Baseline to Week 9