Clinical trial NCT00351910: Efficacy of Seroquel SR in Combination With an Antidepressant in 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 SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment
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: 2006-07-13
Enrollment: 494
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: To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in 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 aged 18 to 65 years
* A documented diagnosis of major depressive disorder

Exclusion Criteria:

* Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment
* Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status
* Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment

Primary outcomes:
measure: To evaluate the efficacy of quetiapine fumarate sustained release
measure: (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.
Secondary outcomes:
measure: If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.
Other outcomes:
Locations:
city: Everton Park
country: Australia
facility: Research Site
state: Queensland
city: Southport
country: Australia
facility: Research Site
state: Queensland
city: Frankston
country: Australia
facility: Research Site
state: Victoria
city: Malvern
country: Australia
facility: Research Site
state: Victoria
city: Prahran
country: Australia
facility: Research Site
state: Victoria
city: Richmond
country: Australia
facility: Research Site
state: Victoria
city: Brisbane
country: Australia
facility: Research Site
city: Assebroek
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Tielt
country: Belgium
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Moncton
country: Canada
facility: Research Site
state: New Brunswick
city: Mount Pearl
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Pointe-claire
country: Canada
facility: Research Site
state: Quebec
city: Brno
country: Czech Republic
facility: Research Site
city: Havirov
country: Czech Republic
facility: Research Site
city: Havlickuv Brod
country: Czech Republic
facility: Research Site
city: Nove Mesto nad Metuji
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Praha 10
country: Czech Republic
facility: Research Site
city: Praha 5
country: Czech Republic
facility: Research Site
city: Praha 8
country: Czech Republic
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Jarvenpaa
country: Finland
facility: Research Site
city: Salo
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Angouleme
country: France
facility: Research Site
city: Arcachon
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Chateau Gontier
country: France
facility: Research Site
city: Elancourt
country: France
facility: Research Site
city: Le Pecq
country: France
facility: Research Site
city: Nimes
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Flekkefjord
country: Norway
facility: Research Site
city: Fyllingsdalen
country: Norway
facility: Research Site
city: Hamar
country: Norway
facility: Research Site
city: Lysaker
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Skien
country: Norway
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Nowy Targ
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
state: Gauteng
city: Durban
country: South Africa
facility: Research Site
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Research Site
state: Western Cape
city: Falkoping
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Halmstad
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Sundsvall
country: Sweden
facility: Research Site
city: Trollhattan
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Seroquel Medical Science Director, 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, Bauer M. Extended-release quetiapine fumarate in the treatment of patients with major depressive disorder: adjunct therapy. Expert Rev Neurother. 2013 Nov;13(11):1183-200. doi: 10.1586/14737175.2013.846519.
citation: Bauer M, Demyttenaere K, El-Khalili N, Thase ME, Papakostas GI, Szamosi J, Earley WR, Eriksson H. Pooled analysis of adjunct extended-release quetiapine fumarate in patients with major depressive disorder according to ongoing SSRI or SNRI treatment. Int Clin Psychopharmacol. 2014 Jan;29(1):16-25. doi: 10.1097/YIC.0000000000000011.
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: Bauer M, McIntyre RS, Szamosi J, Eriksson H. Evaluation of adjunct extended-release quetiapine fumarate on sleep disturbance and quality in patients with major depressive disorder and an inadequate response to on-going antidepressant therapy. Int J Neuropsychopharmacol. 2013 Sep;16(8):1755-65. doi: 10.1017/S146114571300031X. 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: Bauer M, Pretorius HW, Constant EL, Earley WR, Szamosi J, Brecher M. Extended-release quetiapine as adjunct to an antidepressant in patients with major depressive disorder: results of a randomized, placebo-controlled, double-blind study. J Clin Psychiatry. 2009 Apr;70(4):540-9. doi: 10.4088/jcp.08m04629. Epub 2009 Apr 7.