Major Depressive DisorderPhase 3RUBYNCT00789854
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
A Phase 3 study testing Quetiapine XR, Lithium carbonate and SSRI/Venlafaxine in people with Major Depressive Disorder and Treatment Resistant Depression, run by AstraZeneca at 106 sites in 13 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Treatment Resistant Depression
- What is being tested?
- Quetiapine XR, Lithium carbonate and SSRI/Venlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 106 sitesin 13 countries
- Study dates
- Nov 2008to Aug 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
106 sites in 13 countries.
106 sites in 13 countries
Germany32 sites
Research Site
Aachen
Research Site
Achim
Research Site
Augsburg
Research Site
Bad Homburg
Research Site
Bad Honnef
Research Site
Bad Saarow
Research Site
Berlin
Research Site
Bielefeld
Research Site
Bochum
Research Site
Butzbach
Research Site
Chemnitz
Research Site
Dresden
Research Site
Düren
Research Site
Düsseldorf
Research Site
Ellwangen
Research Site
Erbach im Odenwald
Research Site
Gelsenkirchen
Research Site
Gütersloh
Research Site
Halle
Research Site
Hattingen
Research Site
Herborn
Research Site
Kassel
Research Site
Köthen
Research Site
Neu-Isenburg
Research Site
Neubrandenburg
Research Site
Nuremberg
Research Site
Oldenburg
Research Site
Ostfildern
Research Site
Schwerin
Research Site
Stuttgart
Research Site
Westerstede
Research Site
Würzburg
Australia11 sites
Research Site
Brisbane, Queensland
Research Site
Clayton, Victoria
Research Site
Everton Park, Queensland
Research Site
Frankston, Victoria
Research Site
Garran, Australian Capital Territory
Research Site
Gilberton, South Australia
Research Site
Heidelberg, Victoria
Research Site
Malvern, Victoria
Research Site
Prahran, Victoria
Research Site
Richmond, Victoria
Research Site
Townsville, Queensland
Italy9 sites
Research Site
Bolzano
Research Site
Brixen, BZ
Research Site
Bruneck, BZ
Research Site
Cagliari, CA
Research Site
Catania
Research Site
Naples
Research Site
Pisa, PI
Research Site
Roma, RM
Research Site
Roma
Slovakia9 sites
Research Site
Bratislava
Research Site
Krupina
Research Site
Levice
Research Site
Liptovský Mikuláš
Research Site
Michalovce Stranany
Research Site
Prešov
Research Site
Rožňava
Research Site
Zilina-bytcica
Research Site
Zlaté Moravce
United Kingdom8 sites
Research Site
Addlestone, Surrey
Research Site
Coventry
Research Site
Glasgow
Research Site
Harrow
Research Site
Horsham, West Sussex
Research Site
Hull
Research Site
Winnick, Warrington
Research Site
Winsford
Bulgaria7 sites
Research Site
Cerova Koria Village, Veliko Tarnovo
Research Site
Kardzhali
Research Site
Pazardzhik
Research Site
Pleven
Research Site
Rousse
Research Site
Sofia
Research Site
Varna
Austria6 sites
Research Site
Graz
Research Site
Klagenfurt
Research Site
Salzburg
Research Site
Vienna
Research Site
Wels
Research Site
Wiener Neustadt
Spain5 sites
Research Site
Barcelona, Catalonia
Research Site
Langreo, Principality of Asturias
Research Site
Salamanca, Castille and León
Research Site
Vigo, Galicia
Research Site
Zamora, Castille and León
Belgium4 sites
Research Site
Assebroek, Belgium
Research Site
Diest, Belgium
Research Site
Liège, Belgium
Research Site
Tielt
Hungary4 sites
Research Site
Budapest
Research Site
Győr
Research Site
Gyula
Research Site
Nyíregyháza
Portugal4 sites
Research Site
Braga
Research Site
Coimbra
Research Site
Lisbon
Research Site
Santarém
Romania4 sites
Research Site
Bucharest
Research Site
Craiova
Research Site
Galati, Galați County
Research Site
Sibiu
Denmark3 sites
Research Site
Esbjerg N
Research Site
Frederiksberg
Research Site
Odense
About this study
Official title: 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
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.
Read the detailed description
The secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation to week 6 (end of study). Additionally the time of onset of therapeutic effect will be assessed by evaluating efficacy data after the first four days (Day 4) of treatment as well as after the first week of treatment (Day 8). These analyses will also be performed in the subgroups of patients with 2 failed previous antidepressants and patients with 1 failure.
- Being tested
- Quetiapine XR, Lithium carbonate, SSRI/Venlafaxine
- Keywords
- Depression, MDD, TRD
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine XRDrug
Also called Seroquel XR
300 mg once daily (od)
Lithium carbonateDrug
Also called Quilonum Retard
900 mg once daily (od)
SSRI/VenlafaxineDrug
SSRI - doses within label, Venlafaxine dose up to 225 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Add-on Quetiapine XR+SSRI/Venlafaxine | Active comparator | Selective 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. Receives: Drug: Quetiapine XR; Drug: SSRI/Venlafaxine |
| Add-on Lithium+SSRI/Venlafaxine | Active comparator | Selective 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. Receives: Drug: Lithium carbonate; Drug: SSRI/Venlafaxine |
| Monotherapy Quetiapine XR | Active comparator | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) Receives: Drug: Quetiapine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks of treatment
Secondary outcomes (28)
Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients
Number of patients in remission, with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Measured: 6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure
Number of patients in remission with one previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Measured: 6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure
Number of patients in remission with two previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Measured: 6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8
Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤8. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Measured: 6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12
Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤12. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Measured: 6 weeks of treatment
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients
Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better
Measured: 6 week of treatments
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure
Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better
Measured: 6 weeks of treatment
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure
Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better
Measured: 6 weeks of treatment
Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients
Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where lower value shows a larger improvement.
Measured: 6 weeks of treatment
Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure
Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.
Measured: 6 weeks of treatment
Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure
Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.
Measured: 6 weeks of treatment
Change in Clinical Global Impression Scale (CGI-S), All Patients
Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale form 1-7, where a lower value shows a larger improvement.
Measured: 6 weeks of treatment
Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure
Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.
Measured: 6 weeks of treatment
Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure
Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.
Measured: 6 weeks of treatment
Change in Beck Depression Inventory (BDI)
Self-rating assessment of depressive symptoms using Beck Depression Inventory (BDI). Scale from 0-63, where a lower value shows a larger improvement.
Measured: 6 weeks of treatment
Change in Pain, Measured by Visual Analog Scale (VAS)
Self-rating assessment of pain using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.
Measured: 6 weeks of treatment
Change in Anxiety Measured by Visual Analog Scale (VAS)
Self-rating assessment of anxiety using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.
Measured: 6 weeks of treatment
Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory
Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)
Measured: 6 weeks of treatment
Change in Anxiety Measured by STAI, Trait Anxiety Inventory
Self-rating assessment of anxiety measured by State-Trait Anxiety Inventory (STAI), trait anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)
Measured: 6 weeks of treatment
Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4
Sleeping quality measured by Montgomery-Asberg Depression Rating Scale (MADRS) item 4 (reduced sleep) (Scale 0-6, where a lower value shows a larger improvement)
Measured: 6 weeks of treatment
Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)
Self-rated sleeping quality measured by PSQI (Scale 0-21, subscales 0-3, 18 questions, where a lower value shows a larger improvement)
Measured: 6 weeks of treatment
Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component
Self rating assessment of quality in life using SF-36, mental component (Scale 0-100, where a higher value shows a larger improvement)
Measured: 6 weeks of treatment
Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component
Self rating assessment of quality in life using SF-36, physical component (Scale 0-100, where a higher value shows a larger improvement)
Measured: 6 weeks of treatment
Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility
Self rating assessment of quality in life using EQ-5D utility (Scale 0-100, where a higher value shows a larger improvement)
Measured: 6 weeks of treatment
Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)
Self rating assessment of working productivity using WPAI:GH (Scale 0 to number of hours worked during a week multiplied with the salary in Euro, a lower value shows a larger improvement)
Measured: 6 weeks of treatment
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients
The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm (225, 229 or 221).
Measured: 6 weeks of treatment
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure
The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.
Measured: 6 weeks of treatment
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures
The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.
Measured: 6 week of treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- None (open label)
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Bauer, professor, Principal investigator, GermanyBirgit Ekholm, PhD, Study director, AstraZeneca MC Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789854
- Sponsor's protocol ID
- D1443L00044
- Acronym
- RUBY
- Status last verified
- Apr 2012
- First submitted
- 11 Nov 2008
- Last updated
- 23 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23810357
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00789854
- Acronym / sponsor ID
- RUBY / D1443L00044
- Keywords
- Depression, MDD, TRD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Posted 23 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation to week 6 (end of study). Additionally the time of onset of therapeutic effect will be assessed by evaluating efficacy data after the first four days (Day 4) of treatment as well as after the first week of treatment (Day 8). These analyses will also be performed in the subgroups of patients with 2 failed previous antidepressants and patients with 1 failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Add-on Quetiapine XR+SSRI/Venlafaxine | Active comparator | Drug: Quetiapine XR, Drug: SSRI/VenlafaxineSelective 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 comparator | Drug: Lithium carbonate, Drug: SSRI/VenlafaxineSelective 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 comparator | Drug: Quetiapine XRSwitch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 XRAlso: Seroquel XR300 mg once daily (od) | Drug | Add-on Quetiapine XR+SSRI/Venlafaxine, Monotherapy Quetiapine XR |
| Lithium carbonateAlso: Quilonum Retard900 mg once daily (od) | Drug | Add-on Lithium+SSRI/Venlafaxine |
| SSRI/VenlafaxineSSRI - doses within label, Venlafaxine dose up to 225 mg/day | Drug | Add-on Lithium+SSRI/Venlafaxine, Add-on Quetiapine XR+SSRI/Venlafaxine |
Primary outcome
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)
Time frame: 6 weeks treatment
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.
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)
Time frame: 6 weeks of treatment
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.
28 secondary outcomes
Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients
Time frame: 6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure
Time frame: 6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure
Time frame: 6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8
Time frame: 6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12
Time frame: 6 weeks of treatment
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients
Time frame: 6 week of treatments
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure
Time frame: 6 weeks of treatment
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure
Time frame: 6 weeks of treatment
Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients
Time frame: 6 weeks of treatment
Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure
Time frame: 6 weeks of treatment
Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure
Time frame: 6 weeks of treatment
Change in Clinical Global Impression Scale (CGI-S), All Patients
Time frame: 6 weeks of treatment
Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure
Time frame: 6 weeks of treatment
Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure
Time frame: 6 weeks of treatment
Change in Beck Depression Inventory (BDI)
Time frame: 6 weeks of treatment
Change in Pain, Measured by Visual Analog Scale (VAS)
Time frame: 6 weeks of treatment
Change in Anxiety Measured by Visual Analog Scale (VAS)
Time frame: 6 weeks of treatment
Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory
Time frame: 6 weeks of treatment
Change in Anxiety Measured by STAI, Trait Anxiety Inventory
Time frame: 6 weeks of treatment
Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4
Time frame: 6 weeks of treatment
Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 weeks of treatment
Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component
Time frame: 6 weeks of treatment
Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component
Time frame: 6 weeks of treatment
Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility
Time frame: 6 weeks of treatment
Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)
Time frame: 6 weeks of treatment
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients
Time frame: 6 weeks of treatment
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure
Time frame: 6 weeks of treatment
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures
Time frame: 6 week of treatments
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23810357Bauer 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.
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Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Michael Bauer, professor principal investigator
Germany
Birgit Ekholm, PhD study director
AstraZeneca MC Sweden
106 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine XR, Lithium carbonate and SSRI/Venlafaxine in people with Major Depressive Disorder and Treatment Resistant Depression, run by AstraZeneca at 106 sites in 13 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 3 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 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in Germany, Australia, Italy, Slovakia, United Kingdom and 8 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?
Yes. Results are posted in the registry (first posted 23 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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) (time frame: 6 weeks treatment). 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 NCT00789854, which also lists 1 linked publication.
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 23 May 2012.