Major Depressive DisorderPhase 3ONYXNCT00351910
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
A Phase 3 study testing Quetiapine, Amitriptyline and Bupropion in people with Major Depressive Disorder, run by AstraZeneca at 72 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Quetiapine, Amitriptyline and Bupropion
- How many people
- 494 participants
- Where
- 72 sitesin 12 countries
- Study dates
- May 2006to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 65 years
- A documented diagnosis of major depressive disorder
Who cannot join
- 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
Trial locations and contacts
72 sites in 12 countries.
72 sites in 12 countries
France10 sites
Research Site
Angoulême
Research Site
Arcachon
Research Site
Caen
Research Site
Château-Gontier
Research Site
Élancourt
Research Site
Le Pecq
Research Site
Nîmes
Research Site
Paris
Research Site
Rennes
Research Site
Toulouse
Sweden8 sites
Research Site
Falköping
Research Site
Gothenburg
Research Site
Halmstad
Research Site
Malmö
Research Site
Stockholm
Research Site
Sundsvall
Research Site
Trollhättan
Research Site
Uppsala
Australia7 sites
Research Site
Brisbane
Research Site
Everton Park, Queensland
Research Site
Frankston, Victoria
Research Site
Malvern, Victoria
Research Site
Prahran, Victoria
Research Site
Richmond, Victoria
Research Site
Southport, Queensland
Belgium7 sites
Research Site
Assebroek
Research Site
Brussels
Research Site
Ghent
Research Site
Kortrijk
Research Site
Liège
Research Site
Mechelen
Research Site
Tielt
Canada7 sites
Research Site
Edmonton, Alberta
Research Site
Halifax, Nova Scotia
Research Site
Moncton, New Brunswick
Research Site
Mount Pearl, Newfoundland and Labrador
Research Site
Pointe-Claire, Quebec
Research Site
St. John's, Newfoundland and Labrador
Research Site
Toronto, Ontario
Czechia7 sites
Research Site
Brno
Research Site
Havířov
Research Site
Havlíčkův Brod
Research Site
Nové Město nad Metují
Research Site
Olomouc
Research Site
Ostrava
Research Site
Prague
Norway7 sites
Research Site
Bergen
Research Site
Flekkefjord
Research Site
Fyllingsdalen
Research Site
Hamar
Research Site
Lysaker
Research Site
Oslo
Research Site
Skien
Poland6 sites
Research Site
Gdansk
Research Site
Lodz
Research Site
Nowy Targ
Research Site
Szczecin
Research Site
Torun
Research Site
Warsaw
Finland4 sites
Research Site
Helsinki
Research Site
Jarvenpaa
Research Site
Salo
Research Site
Turku
Germany4 sites
Research Site
Augsburg
Research Site
Berlin
Research Site
Cologne
Research Site
Münster
South Africa3 sites
Research Site
Cape Town, Western Cape
Research Site
Durban, KwaZulu-Natal
Research Site
Pretoria, Gauteng
About this study
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
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Quetiapine, Amitriptyline, Bupropion, Citalopram, Duloxetine
- Keywords
- Major Depressive Disorder, MDD
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
AmitriptylineDrug
BupropionDrug
CitalopramDrug
DuloxetineDrug
EscitalopramDrug
FluoxetineDrug
ParoxetineDrug
SertralineDrug
VenlafaxineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startMay 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Seroquel Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351910
- Sponsor's protocol ID
- D1448C00007
- Other IDs
- ONYX, EUDRACT No: 2005-0055053-22
- Acronym
- ONYX
- Status last verified
- Jan 2011
- First submitted
- 12 Jul 2006
- Last updated
- 26 Jan 2011
- Results posted
- No
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.
PubMed 26474010Weisler 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.
PubMed 24816198Weisler 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.
PubMed 24175721Bauer 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.
PubMed 24108148Clayton 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.
PubMed 24067192Bauer 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.
PubMed 23672772Vieta 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.
PubMed 23497790Bauer 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.
PubMed 19358791
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00351910
- Acronym / sponsor ID
- ONYX / D1448C00007
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, MDD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 13 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 18 to 65 years
- A documented diagnosis of major depressive disorder
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine | Drug | – |
| Amitriptyline | Drug | – |
| Bupropion | Drug | – |
| Citalopram | Drug | – |
| Duloxetine | Drug | – |
| Escitalopram | Drug | – |
| Fluoxetine | Drug | – |
| Paroxetine | Drug | – |
| Sertraline | Drug | – |
| Venlafaxine | Drug | – |
Primary outcome
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.
1 secondary outcome
If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
- Derived from this study: PubMed 26474010McIntyre 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.
- Derived from this study: PubMed 24816198Weisler 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.
- Derived from this study: PubMed 24175721Weisler 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.
- Derived from this study: PubMed 24108148Bauer 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.
- Derived from this study: PubMed 24067192Clayton 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.
- Derived from this study: PubMed 23672772Bauer 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.
- Derived from this study: PubMed 23497790Vieta 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.
- Derived from this study: PubMed 19358791Bauer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seroquel Medical Science Director, MD study director
AstraZeneca
72 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine, Amitriptyline and Bupropion in people with Major Depressive Disorder, run by AstraZeneca at 72 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in France, Sweden, Australia, Belgium, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of quetiapine fumarate sustained release. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00351910, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2011.