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Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00388973
Recruitment Status : Completed
First Posted : October 17, 2006
Results First Posted : April 1, 2010
Last Update Posted : April 1, 2010
Sponsor:
Information provided by:
AstraZeneca

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Quetiapine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. Tolerability as Measured by Adverse Event Withdrawals During Treatment [ Time Frame: Baseline to Week 9 ]


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Ages Eligible for Study:   66 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388973


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Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
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San Diego, California, United States
United States, Florida
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Ft Myers, Florida, United States
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Gainsville, Florida, United States
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Sarasota, Florida, United States
United States, Georgia
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Roswell, Georgia, United States
United States, Massachusetts
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Boston, Massachusetts, United States
United States, New York
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Brooklyn, New York, United States
United States, Oregon
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Eugene, Oregon, United States
United States, Pennsylvania
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Jenkintown, Pennsylvania, United States
United States, Tennessee
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Memphis, Tennessee, United States
United States, Texas
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Austin, Texas, United States
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San Antonio, Texas, United States
Argentina
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City Bell, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Buenos Aires, Argentina
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Capital Federal, Argentina
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Cordoba, Argentina
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Mendoza, Argentina
Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Viljandi, Estonia
Finland
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Helsinki, Finland
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Jarvenpaa, Finland
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Kuopio, Finland
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Salo, Finland
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Seinajoki, Finland
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Tampere, Finland
Russian Federation
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Arkhangelsk, Russian Federation
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Izhevsk, Russian Federation
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Lipetsk, Russian Federation
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Moscow, Russian Federation
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Nizhny Novgorod, Russian Federation
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Perm, Russian Federation
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St.-petersburg, Russian Federation
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Stavropol, Russian Federation
Ukraine
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Glevakha, Kiev Region, Ukraine
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kiev, Ukraine
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Lugansk, Ukraine
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Odessa, Ukraine
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Vinnitsa, Ukraine
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Catherine Datto, MD AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Martin Brecher, Seroquel Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00388973     History of Changes
Other Study ID Numbers: D1448C00014
EUDRACT No: 2006-001196-38
First Posted: October 17, 2006    Key Record Dates
Results First Posted: April 1, 2010
Last Update Posted: April 1, 2010
Last Verified: March 2010
Keywords provided by AstraZeneca:
Major Depressive Disorder
MDD
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Behavioral Symptoms
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs