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Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder (ONYX)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quetiapine
Amitriptyline
Bupropion
Citalopram
Duloxetine
Escitalopram
Fluoxetine
Paroxetine
Sertraline
Venlafaxine
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, MDD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.

Full Information

First Posted
July 12, 2006
Last Updated
January 25, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00351910
Brief Title
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
Acronym
ONYX
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

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, MDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
494 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Type
Drug
Intervention Name(s)
Amitriptyline
Intervention Type
Drug
Intervention Name(s)
Bupropion
Intervention Type
Drug
Intervention Name(s)
Citalopram
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Primary Outcome Measure Information:
Title
To evaluate the efficacy of quetiapine fumarate sustained release
Title
(Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.
Secondary Outcome Measure Information:
Title
If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Everton Park
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Southport
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Malvern
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Prahran
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Richmond
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Brisbane
Country
Australia
Facility Name
Research Site
City
Assebroek
Country
Belgium
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Kortrijk
Country
Belgium
Facility Name
Research Site
City
Liege
Country
Belgium
Facility Name
Research Site
City
Mechelen
Country
Belgium
Facility Name
Research Site
City
Tielt
Country
Belgium
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
Research Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Pointe-claire
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Havirov
Country
Czech Republic
Facility Name
Research Site
City
Havlickuv Brod
Country
Czech Republic
Facility Name
Research Site
City
Nove Mesto nad Metuji
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
Country
Czech Republic
Facility Name
Research Site
City
Ostrava
Country
Czech Republic
Facility Name
Research Site
City
Praha 10
Country
Czech Republic
Facility Name
Research Site
City
Praha 5
Country
Czech Republic
Facility Name
Research Site
City
Praha 8
Country
Czech Republic
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Jarvenpaa
Country
Finland
Facility Name
Research Site
City
Salo
Country
Finland
Facility Name
Research Site
City
Turku
Country
Finland
Facility Name
Research Site
City
Angouleme
Country
France
Facility Name
Research Site
City
Arcachon
Country
France
Facility Name
Research Site
City
Caen
Country
France
Facility Name
Research Site
City
Chateau Gontier
Country
France
Facility Name
Research Site
City
Elancourt
Country
France
Facility Name
Research Site
City
Le Pecq
Country
France
Facility Name
Research Site
City
Nimes
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research Site
City
Rennes
Country
France
Facility Name
Research Site
City
Toulouse
Country
France
Facility Name
Research Site
City
Augsburg
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Koln
Country
Germany
Facility Name
Research Site
City
Munster
Country
Germany
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Flekkefjord
Country
Norway
Facility Name
Research Site
City
Fyllingsdalen
Country
Norway
Facility Name
Research Site
City
Hamar
Country
Norway
Facility Name
Research Site
City
Lysaker
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Skien
Country
Norway
Facility Name
Research Site
City
Gdansk
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Nowy Targ
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Pitesti
Country
Romania
Facility Name
Research Site
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Research Site
City
Durban
State/Province
Kwazulu-Natal
Country
South Africa
Facility Name
Research Site
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Research Site
City
Falkoping
Country
Sweden
Facility Name
Research Site
City
Göteborg
Country
Sweden
Facility Name
Research Site
City
Halmstad
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Sundsvall
Country
Sweden
Facility Name
Research Site
City
Trollhattan
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26474010
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.
Results Reference
derived
PubMed Identifier
24816198
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.
Results Reference
derived
PubMed Identifier
24175721
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.
Results Reference
derived
PubMed Identifier
24108148
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.
Results Reference
derived
PubMed Identifier
24067192
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.
Results Reference
derived
PubMed Identifier
23672772
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.
Results Reference
derived
PubMed Identifier
23497790
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.
Results Reference
derived
PubMed Identifier
19358791
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.
Results Reference
derived

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Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

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