Clinical trial NCT00321490: Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled and Active-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: MDD
Quetiapine fumarate, sustained release
Depression
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.


Eligibility criteria: Inclusion Criteria:

* Patient has a documented clinical diagnosis of Major Depressive Disorder.
* Be able to understand and comply with the requirements of the study.
* Able to understand and provide written informed consent

Exclusion Criteria:

* Patients (female) must not be pregnant or lactating
* Current or past diagnosis of stroke or transient ischemic attack (TIA).

Primary outcomes:
measure: Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Secondary outcomes:
measure: Change from randomization to each assessment in the MADRS total score
measure: MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Sherman Oaks
country: United States
facility: Research Site
state: California
city: Wildomar
country: United States
facility: Research Site
state: California
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Bradenton
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Edwardsville
country: United States
facility: Research Site
state: Illinois
city: Lake Charles
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Haverhill
country: United States
facility: Research Site
state: Massachusetts
city: Okemos
country: United States
facility: Research Site
state: Michigan
city: St. Paul
country: United States
facility: Research Site
state: Minnesota
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Princeton
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: New York City
country: United States
facility: Research Site
state: New York
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Mayfield Village
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Salem
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Kirkland
country: United States
facility: Research Site
state: Washington
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
Study officials:
affiliation: AstraZeneca
name: Art Lazarus, MD
role: STUDY_DIRECTOR
References:
citation: McIntyre RS, Gorwood P, Thase ME, Liss C, Desai D, Chen J, Bauer M. Early Symptom Improvement as a Predictor of Response to Extended Release Quetiapine in Major Depressive Disorder. J Clin Psychopharmacol. 2015 Dec;35(6):706-10. doi: 10.1097/JCP.0000000000000416.
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: Clayton AH, Locklear JC, Svedsater H, McIntyre RS. Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate. CNS Spectr. 2014 Apr;19(2):182-96. doi: 10.1017/S1092852913000631. Epub 2013 Sep 25.
citation: Trivedi MH, Bandelow B, Demyttenaere K, Papakostas GI, Szamosi J, Earley W, Eriksson H. Evaluation of the effects of extended release quetiapine fumarate monotherapy on sleep disturbance in patients with major depressive disorder: a pooled analysis of four randomized acute studies. Int J Neuropsychopharmacol. 2013 Sep;16(8):1733-44. doi: 10.1017/S146114571300028X. Epub 2013 May 14.
citation: Vieta E, Bauer M, Montgomery S, McIntyre RS, Szamosi J, Earley WR, Eriksson H. Pooled analysis of sustained response rates for extended release quetiapine fumarate as monotherapy or adjunct to antidepressant therapy in patients with major depressive disorder. J Affect Disord. 2013 Sep 5;150(2):639-43. doi: 10.1016/j.jad.2013.01.052. Epub 2013 Mar 14.
citation: Thase ME, Montgomery S, Papakostas GI, Bauer M, Trivedi MH, Svedsater H, Locklear JC, Gustafsson U, Datto C, Eriksson H. Quetiapine XR monotherapy in major depressive disorder: a pooled analysis to assess the influence of baseline severity on efficacy. Int Clin Psychopharmacol. 2013 May;28(3):113-20. doi: 10.1097/YIC.0b013e32835fb971.
citation: Weisler RH, Montgomery SA, Earley WR, Szamosi J, Lazarus A. Efficacy of extended release quetiapine fumarate monotherapy in patients with major depressive disorder: a pooled analysis of two 6-week, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2012 Jan;27(1):27-39. doi: 10.1097/YIC.0b013e32834d6f91.
citation: Cutler AJ, Montgomery SA, Feifel D, Lazarus A, Astrom M, Brecher M. Extended release quetiapine fumarate monotherapy in major depressive disorder: a placebo- and duloxetine-controlled study. J Clin Psychiatry. 2009 Apr;70(4):526-39. doi: 10.4088/jcp.08m04592. Epub 2009 Apr 7.