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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00351910




Registration number
NCT00351910
Ethics application status
Date submitted
12/07/2006
Date registered
13/07/2006
Date last updated
26/01/2011

Titles & IDs
Public title
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
Scientific 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
Secondary ID [1] 0 0
ONYX
Secondary ID [2] 0 0
D1448C00007
Universal Trial Number (UTN)
Trial acronym
ONYX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the efficacy of quetiapine fumarate sustained release
Timepoint [1] 0 0
Primary outcome [2] 0 0
(Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.
Timepoint [2] 0 0
Secondary outcome [1] 0 0
If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Male or female aged 18 to 65 years
* A documented diagnosis of major depressive disorder
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2007
Sample size
Target
Accrual to date
Final
494
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Everton Park
Recruitment hospital [2] 0 0
Research Site - Southport
Recruitment hospital [3] 0 0
Research Site - Frankston
Recruitment hospital [4] 0 0
Research Site - Malvern
Recruitment hospital [5] 0 0
Research Site - Prahran
Recruitment hospital [6] 0 0
Research Site - Richmond
Recruitment hospital [7] 0 0
Research Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Everton Park
Recruitment postcode(s) [2] 0 0
- Southport
Recruitment postcode(s) [3] 0 0
- Frankston
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment postcode(s) [5] 0 0
- Prahran
Recruitment postcode(s) [6] 0 0
- Richmond
Recruitment postcode(s) [7] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Assebroek
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
Kortrijk
Country [5] 0 0
Belgium
State/province [5] 0 0
Liege
Country [6] 0 0
Belgium
State/province [6] 0 0
Mechelen
Country [7] 0 0
Belgium
State/province [7] 0 0
Tielt
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
New Brunswick
Country [10] 0 0
Canada
State/province [10] 0 0
Newfoundland and Labrador
Country [11] 0 0
Canada
State/province [11] 0 0
Nova Scotia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Brno
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Havirov
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Havlickuv Brod
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Nove Mesto nad Metuji
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Olomouc
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Ostrava
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Praha 10
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Praha 5
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Praha 8
Country [23] 0 0
Finland
State/province [23] 0 0
Helsinki
Country [24] 0 0
Finland
State/province [24] 0 0
Jarvenpaa
Country [25] 0 0
Finland
State/province [25] 0 0
Salo
Country [26] 0 0
Finland
State/province [26] 0 0
Turku
Country [27] 0 0
France
State/province [27] 0 0
Angouleme
Country [28] 0 0
France
State/province [28] 0 0
Arcachon
Country [29] 0 0
France
State/province [29] 0 0
Caen
Country [30] 0 0
France
State/province [30] 0 0
Chateau Gontier
Country [31] 0 0
France
State/province [31] 0 0
Elancourt
Country [32] 0 0
France
State/province [32] 0 0
Le Pecq
Country [33] 0 0
France
State/province [33] 0 0
Nimes
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Rennes
Country [36] 0 0
France
State/province [36] 0 0
Toulouse
Country [37] 0 0
Germany
State/province [37] 0 0
Augsburg
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Koln
Country [40] 0 0
Germany
State/province [40] 0 0
Munster
Country [41] 0 0
Norway
State/province [41] 0 0
Bergen
Country [42] 0 0
Norway
State/province [42] 0 0
Flekkefjord
Country [43] 0 0
Norway
State/province [43] 0 0
Fyllingsdalen
Country [44] 0 0
Norway
State/province [44] 0 0
Hamar
Country [45] 0 0
Norway
State/province [45] 0 0
Lysaker
Country [46] 0 0
Norway
State/province [46] 0 0
Oslo
Country [47] 0 0
Norway
State/province [47] 0 0
Skien
Country [48] 0 0
Poland
State/province [48] 0 0
Gdansk
Country [49] 0 0
Poland
State/province [49] 0 0
Lodz
Country [50] 0 0
Poland
State/province [50] 0 0
Nowy Targ
Country [51] 0 0
Poland
State/province [51] 0 0
Szczecin
Country [52] 0 0
Poland
State/province [52] 0 0
Torun
Country [53] 0 0
Poland
State/province [53] 0 0
Warszawa
Country [54] 0 0
Romania
State/province [54] 0 0
Bucharest
Country [55] 0 0
Romania
State/province [55] 0 0
Pitesti
Country [56] 0 0
South Africa
State/province [56] 0 0
Gauteng
Country [57] 0 0
South Africa
State/province [57] 0 0
Kwazulu-Natal
Country [58] 0 0
South Africa
State/province [58] 0 0
Western Cape
Country [59] 0 0
Sweden
State/province [59] 0 0
Falkoping
Country [60] 0 0
Sweden
State/province [60] 0 0
Göteborg
Country [61] 0 0
Sweden
State/province [61] 0 0
Halmstad
Country [62] 0 0
Sweden
State/province [62] 0 0
Malmo
Country [63] 0 0
Sweden
State/province [63] 0 0
Stockholm
Country [64] 0 0
Sweden
State/province [64] 0 0
Sundsvall
Country [65] 0 0
Sweden
State/province [65] 0 0
Trollhattan
Country [66] 0 0
Sweden
State/province [66] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00351910
Trial related presentations / publications
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.
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, 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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Seroquel Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00351910