Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00789854 | Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients | PHASE3 | COMPLETED | 688 | — | — | Nov 1, 2008 | Aug 1, 2009 | May 23, 2012 | 106 | Australia, Austria +11 |
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 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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Monotherapy Quetiapine XR | ACTIVE_COMPARATOR | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) |
| Name | Type | Description |
|---|---|---|
| Quetiapine XR | DRUG | 300 mg once daily (od) |
| Lithium carbonate | DRUG | 900 mg once daily (od) |
| SSRI/Venlafaxine | DRUG | SSRI - doses within label, Venlafaxine dose up to 225 mg/day |
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 pre...