Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9. [ Time Frame: Baseline to Week 9 ]MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.
- Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q) [ Time Frame: Baseline to Week 9 ]Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life.
- Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q) [ Time Frame: Baseline to Week 9 ]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
- Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A) [ Time Frame: Baseline to Week 9 ]Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety.
- Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index [ Time Frame: Baseline to Week 9 ]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
- Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 [ Time Frame: Baseline to Week 9 ]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
- Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A) [ Time Frame: Baseline to Week 9 ]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
- Tolerability as Measured by Adverse Event Withdrawals During Treatment [ Time Frame: Baseline to Week 9 ]
|Study Start Date:||September 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388973
Show 43 Study Locations
|Study Director:||Catherine Datto, MD||AstraZeneca|