| Primary | 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. | Analysis was 'per protocol'. Exclusion reason from analysis: Violation of exclusion/inclusion criteria; Non-compliance regarding prohibited concomitant medication, Total unavailability of MADRS score after randomization, Patient not treated with any dose of study drug after randomization, Non-compliance regarding titration to 300 mg quetiapine/d. | Posted | Aug 2010 | Least Squares Mean | Standard Error | scores on a scale | | 6 weeks treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-16.2± 0.843(0.843 to )
- OG001-17.2± 0.826(0.826 to )
- OG002-14.9± 0.97(0.97 to )
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Add-on quetiapine XR was tested versus add-on lithium for non-inferiority. The null hypothesis was that the add-on quetiapine treatment was non-inferior to add-on lithium. | ANCOVA | Non-inferiority between add-on quetiapine XR and add-on lithium was shown in the Per Protocol analysis set. | | The CI is for comparing add-on quetiapine versus add-on Lithium. The CI = confidence interval was adjusted for multiple comparisons. The -0.05 value should have been +3 or above to fail to reject the null hypothesis. | Mean Difference (Final Values) | -2.322 | | | | 97.5 | -4.6 | -0.05 | | | | Yes | |
|
| Primary | 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. | | Posted | Aug 2010 | Least Squares Mean | Standard Error | scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Number | | Participants | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Number | | Participants | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Number | | Participants | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Number | | Participants | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Number | | Participants | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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 | | Posted | Aug 2010 | Number | | Participants | | 6 week of treatments | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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 | | Posted | Aug 2010 | Number | | Participants | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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 | | Posted | Aug 2010 | Number | | Participants | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Mean | Standard Deviation | scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Mean | Standard Deviation | scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Mean | Standard Deviation | scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Least Squares Mean | Standard Error | scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Least Squares Mean | Standard Error | scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Least Squares Mean | Standard Error | scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Least Squares Mean | Standard Error | scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Least Squares Mean | Standard Error | scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Least Squares Mean | Standard Error | scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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) | | Posted | Aug 2010 | Least Squares Mean | Standard Error | Scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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) | | Posted | Aug 2010 | Least Squares Mean | Standard Error | Scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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) | | Posted | Aug 2010 | Least Squares Mean | Standard Error | MADRS item 4 score | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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) | | Posted | Aug 2010 | Least Squares Mean | Standard Error | Scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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) | | Posted | Aug 2010 | Least Squares Mean | Standard Error | Scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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) | | Posted | Aug 2010 | Least Squares Mean | Standard Error | Scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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) | | Posted | Aug 2010 | Least Squares Mean | Standard Error | Scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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) | | Posted | Aug 2010 | Least Squares Mean | Standard Error | Scores on a scale | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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). | | Posted | Aug 2010 | Number | | Participants | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Number | | Participants | | 6 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |
| Secondary | 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. | | Posted | Aug 2010 | Number | | Participants | | 6 week of treatments | | | | ID | Title | Description |
|---|
| OG000 | Quetiapine XR Mono | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) | | OG001 | Add-on Quetiapine XR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od) | | OG002 | Add-on Lithium | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od) |
| |