Major Depressive Disorder Clinical Trial
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
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.
Status | Completed |
Enrollment | 338 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 66 Years and older |
Eligibility |
Inclusion Criteria: - Male or female patients, 66 years or older, with a documented clinical diagnosis of MDD. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Research Site | Buenos Aires | |
Argentina | Research Site | Capital Federal | |
Argentina | Research Site | City Bell | Buenos Aires |
Argentina | Research Site | Cordoba | |
Argentina | Research Site | La Plata | Buenos Aires |
Argentina | Research Site | Mendoza | |
Estonia | Research Site | Tallinn | |
Estonia | Research Site | Tartu | |
Estonia | Research Site | Viljandi | |
Finland | Research Site | Helsinki | |
Finland | Research Site | Jarvenpaa | |
Finland | Research Site | Kuopio | |
Finland | Research Site | Salo | |
Finland | Research Site | Seinajoki | |
Finland | Research Site | Tampere | |
Russian Federation | Research Site | Arkhangelsk | |
Russian Federation | Research Site | Izhevsk | |
Russian Federation | Research Site | Lipetsk | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Nizhny Novgorod | |
Russian Federation | Research Site | Perm | |
Russian Federation | Research Site | St.-petersburg | |
Russian Federation | Research Site | Stavropol | |
Ukraine | Research Site | Dnipropetrovsk | |
Ukraine | Research Site | Donetsk | |
Ukraine | Research Site | Glevakha | Kiev Region |
Ukraine | Research Site | Kiev | |
Ukraine | Research Site | Lugansk | |
Ukraine | Research Site | Odessa | |
Ukraine | Research Site | Vinnitsa | |
United States | Research Site | Austin | Texas |
United States | Research Site | Birmingham | Alabama |
United States | Research Site | Boston | Massachusetts |
United States | Research Site | Brooklyn | New York |
United States | Research Site | Eugene | Oregon |
United States | Research Site | Ft Myers | Florida |
United States | Research Site | Gainsville | Florida |
United States | Research Site | Jenkintown | Pennsylvania |
United States | Research Site | Memphis | Tennessee |
United States | Research Site | Roswell | Georgia |
United States | Research Site | San Antonio | Texas |
United States | Research Site | San Diego | California |
United States | Research Site | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Argentina, Estonia, Finland, Russian Federation, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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. | Baseline to Week 9 | No |
Secondary | 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 | Baseline to Week 9 | No |
Secondary | 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. | Baseline to Week 9 | No |
Secondary | 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 | Baseline to Week 9 | No |
Secondary | 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 | Baseline to Week 9 | Yes |
Secondary | 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 | Baseline to Week 9 | No |
Secondary | Tolerability as Measured by Adverse Event Withdrawals During Treatment | Baseline to Week 9 | Yes |
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