Major Depressive DisorderPhase 3NCT00388973
Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder
A Phase 3 study testing Quetiapine in people with Major Depressive Disorder, run by AstraZeneca at 43 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Quetiapine
- How many people
- 338 participants
- Where
- 43 sitesin 6 countries
- Study dates
- Sep 2006to Dec 2007
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female patients, 66 years or older, with a documented clinical diagnosis of MDD.
Who cannot join
- 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
Trial locations and contacts
43 sites in 6 countries.
43 sites in 6 countries
United States13 sites
Research Site
Austin, Texas
Research Site
Birmingham, Alabama
Research Site
Boston, Massachusetts
Research Site
Brooklyn, New York
Research Site
Eugene, Oregon
Research Site
Fort Myers, Florida
Research Site
Gainsville, Florida
Research Site
Jenkintown, Pennsylvania
Research Site
Memphis, Tennessee
Research Site
Roswell, Georgia
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Sarasota, Florida
Russia8 sites
Research Site
Arkhangelsk
Research Site
Izhevsk
Research Site
Lipetsk
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Perm
Research Site
Saint Petersburg
Research Site
Stavropol
Ukraine7 sites
Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Hlevakha, Kyiv Oblast
Research Site
Kiev
Research Site
Luhansk
Research Site
Odesa
Research Site
Vinnitsa
Argentina6 sites
Research Site
Buenos Aires
Research Site
Capital Federal
Research Site
City Bell, Buenos Aires
Research Site
Córdoba, Córdoba Province
Research Site
La Plata, Buenos Aires
Research Site
Mendoza, Mendoza Province
Finland6 sites
Research Site
Helsinki, Finland
Research Site
Jarvenpaa
Research Site
Kuopio
Research Site
Salo
Research Site
Seinäjoki
Research Site
Tampere, Finland
Estonia3 sites
Research Site
Tallinn
Research Site
Tartu, Estonia
Research Site
Viljandi
About this study
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Quetiapine
- Keywords
- Major Depressive Disorder, MDD
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 9
Secondary outcomes (7)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Week 9
Tolerability as Measured by Adverse Event Withdrawals During Treatment
Measured: Baseline to Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Catherine Datto, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388973
- Sponsor's protocol ID
- D1448C00014
- Other IDs
- EUDRACT No: 2006-001196-38
- Status last verified
- Mar 2010
- First submitted
- 16 Oct 2006
- Last updated
- 1 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 24816198Weisler 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.
PubMed 24175720Montgomery 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.
PubMed 24162081Locklear JC, Svedsater 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.
PubMed 23639212Katila 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.
PubMed 23567397