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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00789854
Registration number
NCT00789854
Ethics application status
Date submitted
11/11/2008
Date registered
13/11/2008
Date last updated
23/05/2012
Titles & IDs
Public title
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
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Scientific 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
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Secondary ID [1]
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0
D1443L00044
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Universal Trial Number (UTN)
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Trial acronym
RUBY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
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Treatment Resistant Depression
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Quetiapine XR
Treatment: Drugs - Lithium carbonate
Treatment: Drugs - SSRI/Venlafaxine
Active Comparator: Add-on Quetiapine XR+SSRI/Venlafaxine - 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.
Active Comparator: Add-on Lithium+SSRI/Venlafaxine - 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.
Active Comparator: Monotherapy Quetiapine XR - Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
Treatment: Drugs: Quetiapine XR
300 mg once daily (od)
Treatment: Drugs: Lithium carbonate
900 mg once daily (od)
Treatment: Drugs: SSRI/Venlafaxine
SSRI - doses within label, Venlafaxine dose up to 225 mg/day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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6 weeks treatment
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Primary outcome [2]
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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)
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Assessment method [2]
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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.
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Timepoint [2]
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6 weeks of treatment
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Secondary outcome [1]
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Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS =10, All Patients
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Assessment method [1]
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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.
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Timepoint [1]
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6 weeks of treatment
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Secondary outcome [2]
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Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) =10, Patients With One Previous Treatment Failure
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Assessment method [2]
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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.
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Timepoint [2]
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6 weeks of treatment
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Secondary outcome [3]
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Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) =10, Patients With Two Previous Treatment Failure
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Assessment method [3]
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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.
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Timepoint [3]
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6 weeks of treatment
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Secondary outcome [4]
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Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) =8
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Assessment method [4]
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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.
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Timepoint [4]
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0
6 weeks of treatment
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Secondary outcome [5]
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Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) =12
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Assessment method [5]
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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.
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Timepoint [5]
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6 weeks of treatment
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Secondary outcome [6]
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Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced = 50%, All Patients
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Assessment method [6]
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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
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Timepoint [6]
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6 week of treatments
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Secondary outcome [7]
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Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced = 50%, Patients With One Previous Treatment Failure
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Assessment method [7]
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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
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Timepoint [7]
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0
6 weeks of treatment
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Secondary outcome [8]
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Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced = 50%, Patients With Two Previous Treatment Failure
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Assessment method [8]
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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
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Timepoint [8]
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6 weeks of treatment
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Secondary outcome [9]
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Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients
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Assessment method [9]
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Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where lower value shows a larger improvement.
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Timepoint [9]
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6 weeks of treatment
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Secondary outcome [10]
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Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure
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Assessment method [10]
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Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.
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Timepoint [10]
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6 weeks of treatment
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Secondary outcome [11]
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Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure
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Assessment method [11]
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Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.
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Timepoint [11]
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0
6 weeks of treatment
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Secondary outcome [12]
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Change in Clinical Global Impression Scale (CGI-S), All Patients
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Assessment method [12]
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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.
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Timepoint [12]
0
0
6 weeks of treatment
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Secondary outcome [13]
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Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure
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Assessment method [13]
0
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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.
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Timepoint [13]
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0
6 weeks of treatment
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Secondary outcome [14]
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Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure
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Assessment method [14]
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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.
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Timepoint [14]
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6 weeks of treatment
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Secondary outcome [15]
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Change in Beck Depression Inventory (BDI)
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Assessment method [15]
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Self-rating assessment of depressive symptoms using Beck Depression Inventory (BDI). Scale from 0-63, where a lower value shows a larger improvement.
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Timepoint [15]
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6 weeks of treatment
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Secondary outcome [16]
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Change in Pain, Measured by Visual Analog Scale (VAS)
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Assessment method [16]
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Self-rating assessment of pain using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.
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Timepoint [16]
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6 weeks of treatment
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Secondary outcome [17]
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Change in Anxiety Measured by Visual Analog Scale (VAS)
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Assessment method [17]
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Self-rating assessment of anxiety using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.
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Timepoint [17]
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6 weeks of treatment
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Secondary outcome [18]
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Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory
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Assessment method [18]
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Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)
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Timepoint [18]
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6 weeks of treatment
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Secondary outcome [19]
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Change in Anxiety Measured by STAI, Trait Anxiety Inventory
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Assessment method [19]
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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)
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Timepoint [19]
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6 weeks of treatment
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Secondary outcome [20]
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Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4
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Assessment method [20]
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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)
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Timepoint [20]
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6 weeks of treatment
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Secondary outcome [21]
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Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)
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Assessment method [21]
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Self-rated sleeping quality measured by PSQI (Scale 0-21, subscales 0-3, 18 questions, where a lower value shows a larger improvement)
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Timepoint [21]
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6 weeks of treatment
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Secondary outcome [22]
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Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component
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Assessment method [22]
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Self rating assessment of quality in life using SF-36, mental component (Scale 0-100, where a higher value shows a larger improvement)
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Timepoint [22]
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0
6 weeks of treatment
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Secondary outcome [23]
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Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component
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Assessment method [23]
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Self rating assessment of quality in life using SF-36, physical component (Scale 0-100, where a higher value shows a larger improvement)
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Timepoint [23]
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0
6 weeks of treatment
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Secondary outcome [24]
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Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility
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Assessment method [24]
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Self rating assessment of quality in life using EQ-5D utility (Scale 0-100, where a higher value shows a larger improvement)
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Timepoint [24]
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6 weeks of treatment
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Secondary outcome [25]
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Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)
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Assessment method [25]
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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)
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Timepoint [25]
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6 weeks of treatment
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Secondary outcome [26]
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Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients
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Assessment method [26]
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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).
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Timepoint [26]
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6 weeks of treatment
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Secondary outcome [27]
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Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure
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Assessment method [27]
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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.
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Timepoint [27]
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6 weeks of treatment
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Secondary outcome [28]
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Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures
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Assessment method [28]
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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.
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Timepoint [28]
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6 week of treatments
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Eligibility
Key inclusion criteria
- 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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2009
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Sample size
Target
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Accrual to date
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Final
688
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Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC
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Recruitment hospital [1]
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Research Site - Garran
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Recruitment hospital [2]
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Research Site - Brisbane
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Recruitment hospital [3]
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Research Site - Everton Park
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Recruitment hospital [4]
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Research Site - Townsville
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Recruitment hospital [5]
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Research Site - Gilberton
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Recruitment hospital [6]
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Research Site - Clayton
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Recruitment hospital [7]
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Research Site - Frankston
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Recruitment hospital [8]
0
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Research Site - Heidelberg
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Recruitment hospital [9]
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Research Site - Malvern
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Recruitment hospital [10]
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Research Site - Prahran
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Recruitment hospital [11]
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Research Site - Richmond
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Recruitment postcode(s) [1]
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- Garran
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Recruitment postcode(s) [2]
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- Brisbane
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Recruitment postcode(s) [3]
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- Everton Park
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Recruitment postcode(s) [4]
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- Townsville
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Recruitment postcode(s) [5]
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- Gilberton
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Recruitment postcode(s) [6]
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- Clayton
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Recruitment postcode(s) [7]
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0
- Frankston
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Recruitment postcode(s) [8]
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0
- Heidelberg
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Recruitment postcode(s) [9]
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0
- Malvern
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Recruitment postcode(s) [10]
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0
- Prahran
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Recruitment postcode(s) [11]
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- Richmond
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Recruitment outside Australia
Country [1]
0
0
Austria
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State/province [1]
0
0
Graz
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Country [2]
0
0
Austria
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State/province [2]
0
0
Klagenfurt
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Country [3]
0
0
Austria
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State/province [3]
0
0
Salzburg
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Country [4]
0
0
Austria
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State/province [4]
0
0
Wels
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Country [5]
0
0
Austria
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State/province [5]
0
0
Wiener NEUSTADT
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Country [6]
0
0
Austria
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State/province [6]
0
0
Wien
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Country [7]
0
0
Belgium
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State/province [7]
0
0
Assebroek
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Country [8]
0
0
Belgium
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State/province [8]
0
0
Diest
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Country [9]
0
0
Belgium
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State/province [9]
0
0
Liege
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Country [10]
0
0
Belgium
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State/province [10]
0
0
Tielt
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Country [11]
0
0
Bulgaria
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State/province [11]
0
0
Veliko Tarnovo
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Country [12]
0
0
Bulgaria
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State/province [12]
0
0
Kardjali
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Country [13]
0
0
Bulgaria
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State/province [13]
0
0
Pazardjik
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Country [14]
0
0
Bulgaria
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State/province [14]
0
0
Pleven
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Country [15]
0
0
Bulgaria
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State/province [15]
0
0
Ruse
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Country [16]
0
0
Bulgaria
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State/province [16]
0
0
Sofia
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Country [17]
0
0
Bulgaria
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State/province [17]
0
0
Varna
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Country [18]
0
0
Denmark
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State/province [18]
0
0
Esbjerg N
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Country [19]
0
0
Denmark
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State/province [19]
0
0
Frederiksberg
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Country [20]
0
0
Denmark
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State/province [20]
0
0
Odense
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Country [21]
0
0
Germany
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State/province [21]
0
0
Aachen
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Country [22]
0
0
Germany
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State/province [22]
0
0
Achim
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Country [23]
0
0
Germany
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State/province [23]
0
0
Augsburg
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Country [24]
0
0
Germany
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State/province [24]
0
0
Bad Homburg
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Country [25]
0
0
Germany
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State/province [25]
0
0
Bad Honnef
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Country [26]
0
0
Germany
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State/province [26]
0
0
Bad Saarow
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Country [27]
0
0
Germany
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State/province [27]
0
0
Berlin
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Country [28]
0
0
Germany
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State/province [28]
0
0
Bielefeld
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Country [29]
0
0
Germany
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State/province [29]
0
0
Bochum
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Country [30]
0
0
Germany
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State/province [30]
0
0
Butzbach
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Country [31]
0
0
Germany
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State/province [31]
0
0
Chemnitz
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Country [32]
0
0
Germany
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State/province [32]
0
0
Dresden
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Country [33]
0
0
Germany
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State/province [33]
0
0
Duren
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Country [34]
0
0
Germany
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State/province [34]
0
0
Dusseldorf
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Country [35]
0
0
Germany
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State/province [35]
0
0
Ellwangen
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Country [36]
0
0
Germany
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State/province [36]
0
0
Erbach
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Country [37]
0
0
Germany
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State/province [37]
0
0
Gelsenkirchen
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Country [38]
0
0
Germany
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State/province [38]
0
0
Gutersloh
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Country [39]
0
0
Germany
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State/province [39]
0
0
Halle
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Country [40]
0
0
Germany
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State/province [40]
0
0
Hattingen
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Country [41]
0
0
Germany
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State/province [41]
0
0
Herborn
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Country [42]
0
0
Germany
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State/province [42]
0
0
Kassel
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Country [43]
0
0
Germany
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State/province [43]
0
0
Kothen
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Country [44]
0
0
Germany
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State/province [44]
0
0
Neu-isenburg
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Country [45]
0
0
Germany
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State/province [45]
0
0
Neubrandenburg
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Country [46]
0
0
Germany
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State/province [46]
0
0
Nurnberg
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Country [47]
0
0
Germany
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State/province [47]
0
0
Oldenburg
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Country [48]
0
0
Germany
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State/province [48]
0
0
Ostfildern
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Country [49]
0
0
Germany
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State/province [49]
0
0
Schwerin
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Country [50]
0
0
Germany
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State/province [50]
0
0
Stuttgart
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Country [51]
0
0
Germany
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State/province [51]
0
0
Westerstede
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Country [52]
0
0
Germany
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State/province [52]
0
0
Wurzburg
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Country [53]
0
0
Hungary
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State/province [53]
0
0
Budapest
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Italy
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Italy
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Italy
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Italy
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Italy
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Roma
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Portugal
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Portugal
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Romania
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Bucharest
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Romania
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Galati
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Romania
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Sibiu
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Bratislava
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Levice
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Slovakia
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Presov
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Slovakia
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Asturias
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Cataluna
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Galicia
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United Kingdom
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Surrey
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United Kingdom
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Warrington
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United Kingdom
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West Sussex
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United Kingdom
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Coventry
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Glasgow
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United Kingdom
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Harrow
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United Kingdom
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Hull
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United Kingdom
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Winsford
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Funding & Sponsors
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Commercial sector/Industry
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Name
AstraZeneca
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00789854
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Contacts
Principal investigator
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Michael Bauer, professor
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Germany
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00789854
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