Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SSRI/Venlafaxine · 1 trial · 2 indications
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...
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SSRI/Clomipramine is a small molecule being studied for use in Major Depressive Disorder and Obsessive Compulsive Disorder. It is an investigational therapy in Phase 3 clinical development for these psychiatric conditions. The drug is being developed by AstraZeneca PLC.
SSRI/Clomipramine is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the drug for psychiatric indications including Major Depressive Disorder and Obsessive Compulsive Disorder.
SSRI/Clomipramine is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 3 trials for this drug have been completed, with studies conducted in multiple countries across Europe and Australia.
SSRI/Clomipramine has been studied in two completed Phase 3 clinical trials. One trial, NCT00254735, evaluated the drug in patients with Obsessive Compulsive Disorder in Germany. Another trial, NCT00789854, compared the drug in patients with Major Depressive Disorder and Treatment Resistant Depression across multiple countries.
SSRI/Clomipramine is being studied in clinical trials that also involve quetiapine. The trial NCT00254735 examined quetiapine augmentation in Obsessive Compulsive Disorder, and NCT00789854 compared quetiapine XR with lithium augmentation in treatment resistant depression. SSRI/Clomipramine itself is a separate drug being evaluated in these studies.