Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
RUBY
A Randomised, 6-week, Multicentre, Open-label, Rater-blinded Parallel Group Study Comparing Quetiapine Extended Release Monotherapy and Augmentation With Lithium Augmentation in Patients With Treatment Resistant Depression
1 other identifier
interventional
688
12 countries
100
Brief Summary
The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine versus Quetiapine extended release monotherapy in subjects with treatment resistant depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. As an independent objective, the primary objective will also be evaluated in two subgroups of patients: (1) patients who were resistant to two previous antidepressant therapies and (2) in the subgroup of patients with one previous failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Nov 2008
Shorter than P25 for phase_3 major-depressive-disorder
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 11, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
May 23, 2012
CompletedMay 23, 2012
April 1, 2012
9 months
November 11, 2008
August 4, 2010
April 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)
Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.
6 weeks treatment
Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)
Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.
6 weeks of treatment
Secondary Outcomes (28)
Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients
6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure
6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure
6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8
6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12
6 weeks of treatment
- +23 more secondary outcomes
Study Arms (3)
Add-on Quetiapine XR+SSRI/Venlafaxine
ACTIVE COMPARATORSelective serotonin reuptake inhibitors (SSRI) or Venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od). From previous anti-depressant treatment 64% of the patients had SSRI and 35% had Venlafaxine at baseline.
Add-on Lithium+SSRI/Venlafaxine
ACTIVE COMPARATORSelective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od). From previous anti-depressant treatment 67% of the patients had SSRI and 33% had Venlafaxine at baseline.
Monotherapy Quetiapine XR
ACTIVE COMPARATORSwitch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
Interventions
300 mg once daily (od)
900 mg once daily (od)
SSRI - doses within label, Venlafaxine dose up to 225 mg/day
Eligibility Criteria
You may qualify if:
- Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode
- Current episode of depression present, at least 42 days prior to enrolment but not more than 18 months
- MADRS-Score ≥ 25 at enrolment and randomisation
You may not qualify if:
- Patients with a DSM-IV Axis I disorder other than MDD within 6 months of randomisation
- Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
- Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or have made a suicide attempt within the past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (106)
Research Site
Garran, Australian Capital Territory, Australia
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Brisbane, Queensland, Australia
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Everton Park, Queensland, Australia
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Townsville, Queensland, Australia
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Gilberton, South Australia, Australia
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Clayton, Victoria, Australia
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Frankston, Victoria, Australia
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Heidelberg, Victoria, Australia
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Malvern, Victoria, Australia
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Prahran, Victoria, Australia
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Richmond, Victoria, Australia
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Graz, Austria
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Klagenfurt, Austria
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Salzburg, Austria
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Vienna, Austria
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Wels, Austria
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Wiener Neustadt, Austria
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Assebroek, Belgium, Belgium
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Diest, Belgium, Belgium
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Liège, Belgium, Belgium
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Tielt, Belgium
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Cerova Koria Village, Veliko Tarnovo, Bulgaria
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Kardzhali, Bulgaria
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Pazardzhik, Bulgaria
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Pleven, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Esbjerg N, Denmark
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Frederiksberg, Denmark
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Odense, Denmark
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Aachen, Germany
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Achim, Germany
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Augsburg, Germany
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Bad Homburg, Germany
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Bad Honnef, Germany
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Bad Saarow, Germany
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Berlin, Germany
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Bielefeld, Germany
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Bochum, Germany
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Butzbach, Germany
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Chemnitz, Germany
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Dresden, Germany
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Düren, Germany
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Düsseldorf, Germany
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Ellwangen, Germany
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Erbach im Odenwald, Germany
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Gelsenkirchen, Germany
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Gütersloh, Germany
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Halle, Germany
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Hattingen, Germany
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Herborn, Germany
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Kassel, Germany
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Köthen, Germany
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Neu-Isenburg, Germany
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Neubrandenburg, Germany
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Nuremberg, Germany
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Oldenburg, Germany
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Ostfildern, Germany
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Schwerin, Germany
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Stuttgart, Germany
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Westerstede, Germany
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Würzburg, Germany
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Budapest, Hungary
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Győr, Hungary
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Gyula, Hungary
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Nyíregyháza, Hungary
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Brixen, BZ, Italy
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Bruneck, BZ, Italy
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Cagliari, CA, Italy
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Pisa, PI, Italy
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Roma, RM, Italy
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Bolzano, Italy
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Catania, Italy
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Napoli, Italy
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Roma, Italy
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Braga, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Santarém, Portugal
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Galati, Galați County, Romania
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Bucharest, Romania
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Craiova, Romania
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Sibiu, Romania
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Bratislava, Slovakia
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Krupina, Slovakia
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Levice, Slovakia
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Liptovský Mikuláš, Slovakia
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Michalovce Stranany, Slovakia
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Prešov, Slovakia
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Rožňava, Slovakia
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Zilina-bytcica, Slovakia
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Zlaté Moravce, Slovakia
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Salamanca, Castille and León, Spain
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Zamora, Castille and León, Spain
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Barcelona, Catalonia, Spain
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Vigo, Galicia, Spain
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Langreo, Principality of Asturias, Spain
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Addlestone, Surrey, United Kingdom
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Winnick, Warrington, United Kingdom
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Horsham, West Sussex, United Kingdom
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Coventry, United Kingdom
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Glasgow, United Kingdom
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Harrow, United Kingdom
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Hull, United Kingdom
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Winsford, United Kingdom
Related Publications (1)
Bauer M, Dell'osso L, Kasper S, Pitchot W, Dencker Vansvik E, Kohler J, Jorgensen L, Montgomery SA. Extended-release quetiapine fumarate (quetiapine XR) monotherapy and quetiapine XR or lithium as add-on to antidepressants in patients with treatment-resistant major depressive disorder. J Affect Disord. 2013 Oct;151(1):209-19. doi: 10.1016/j.jad.2013.05.079. Epub 2013 Jun 27.
PMID: 23810357DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bauer, professor
Germany
- STUDY DIRECTOR
Birgit Ekholm, PhD
AstraZeneca MC Sweden
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2008
First Posted
November 13, 2008
Study Start
November 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
May 23, 2012
Results First Posted
May 23, 2012
Record last verified: 2012-04