Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
quetiapine · 1 trial · 2 indications
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
| Arm | Type | Description |
|---|---|---|
| Quetiapine Extended Release | EXPERIMENTAL | Lithium or valproate at stable doses within seric therapeutic levels |
| Sertraline | ACTIVE_COMPARATOR | Lithium or valproate at stable doses within seric therapeutic levels |
| Name | Type | Description |
|---|---|---|
| Extended release quetiapine (quetiapine XR) | DRUG | Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length. Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study. |
| Sertraline | DRUG | Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length. Sertraline titration: 50 mg on day 1-3, 100 mg on day 4, and flexible doses of 50 to 200 mg/d from day 5 to the end of the study. |
| adequate mood stabilizer | DRUG | An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively). |
Inclusion Criteria: * Adult ambulatory patients diagnosed of bipolar disorder I or II, current depressive episode (DSM-IV-TR 4ª Ed: 296.5x or 296.89 codes) * Have been treated with only one mood stabilizer (lithium or valproate) in optimal and stable doses during at least the previous 4 weeks to ra...
Quetiapine is an investigational small molecule being studied for the treatment of bipolar disorder, specifically bipolar depression. It is being evaluated as an add-on therapy in patients with acute bipolar depression. The drug is currently in Phase 3 clinical development.
Quetiapine is being developed by AstraZeneca PLC, a pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with bipolar disorder.
Quetiapine is currently in Phase 3 clinical development for the treatment of bipolar disorder. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied in a clinical trial setting to assess its effects in patients with bipolar depression.
Quetiapine is being studied in a Phase 3 clinical trial with the identifier NCT00857584. This trial, titled 'Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy', has been completed and enrolled 27 participants in Spain. The study was active-controlled and randomized.
Quetiapine is also known as quetiapine XR, which refers to the extended-release formulation of the drug. In clinical trials, this formulation is being evaluated for its efficacy in treating bipolar depression when used as an add-on therapy.