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

Study Description

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

Study Design

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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

MedlinePlus Genetics related topics: Depression

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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 :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Contacts and Locations

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

Locations

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United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
San Diego, California, United States
United States, Florida
Research Site
Ft Myers, Florida, United States
Research Site
Gainsville, Florida, United States
Research Site
Sarasota, Florida, United States
United States, Georgia
Research Site
Roswell, Georgia, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, New York
Research Site
Brooklyn, New York, United States
United States, Oregon
Research Site
Eugene, Oregon, United States
United States, Pennsylvania
Research Site
Jenkintown, Pennsylvania, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
United States, Texas
Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States
Argentina
Research Site
City Bell, Buenos Aires, Argentina
Research Site
La Plata, Buenos Aires, Argentina
Research Site
Buenos Aires, Argentina
Research Site
Capital Federal, Argentina
Research Site
Cordoba, Argentina
Research Site
Mendoza, Argentina
Estonia
Research Site
Tallinn, Estonia
Research Site
Tartu, Estonia
Research Site
Viljandi, Estonia
Finland
Research Site
Helsinki, Finland
Research Site
Jarvenpaa, Finland
Research Site
Kuopio, Finland
Research Site
Salo, Finland
Research Site
Seinajoki, Finland
Research Site
Tampere, Finland
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, Russian Federation
Ukraine
Research Site
Glevakha, Kiev Region, Ukraine
Research Site
Dnipropetrovsk, Ukraine
Research Site
Donetsk, Ukraine
Research Site
Kiev, Ukraine
Research Site
Lugansk, Ukraine
Research Site
Odessa, Ukraine
Research Site
Vinnitsa, Ukraine

Sponsors and Collaborators

AstraZeneca

Investigators

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Study Director:	Catherine Datto, MD	AstraZeneca

More Information

Additional Information:

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

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

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.

Weisler 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. Review.

Montgomery 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.

Locklear JC, Svedsäter 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.

Katila 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.

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Responsible Party:	Martin Brecher, Seroquel Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00388973
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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Disease Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms	Quetiapine Fumarate Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs

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