Clinical trial NCT00388973: Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
MDD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-17
Enrollment: 338
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.
timeFrame: Baseline to Week 9
Secondary outcomes:
measure: Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)
timeFrame: Baseline to Week 9
measure: Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)
timeFrame: Baseline to Week 9
measure: Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)
timeFrame: Baseline to Week 9
measure: Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index
timeFrame: Baseline to Week 9
measure: Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10
timeFrame: Baseline to Week 9
measure: Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)
timeFrame: Baseline to Week 9
measure: Tolerability as Measured by Adverse Event Withdrawals During Treatment
timeFrame: Baseline to Week 9
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: San Diego
country: United States
facility: Research Site
state: California
city: Ft Myers
country: United States
facility: Research Site
state: Florida
city: Gainsville
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Roswell
country: United States
facility: Research Site
state: Georgia
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Jenkintown
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: City Bell
country: Argentina
facility: Research Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Research Site
city: Capital Federal
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Viljandi
country: Estonia
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Jarvenpaa
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Salo
country: Finland
facility: Research Site
city: Seinajoki
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Lipetsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: St.-petersburg
country: Russian Federation
facility: Research Site
city: Stavropol
country: Russian Federation
facility: Research Site
city: Glevakha
country: Ukraine
facility: Research Site
state: Kiev Region
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Lugansk
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Vinnitsa
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Catherine Datto, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Locklear 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.
citation: 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.