Approval Probability
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TC-5214 · 6 trials · 4 indications
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.
The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.
| Arm | Type | Description |
|---|---|---|
| TC-5214 | EXPERIMENTAL | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID |
| Placebo | PLACEBO_COMPARATOR | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID |
| 0.1 mg BID TC-5214 | EXPERIMENTAL | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID |
| 1 mg BID TC-5214 | EXPERIMENTAL | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID |
| 4 mg BID TC-5214 | EXPERIMENTAL | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID |
| SSRI/Serotonin/SNRI + TC-5214 1-4 mg | EXPERIMENTAL | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 mg BID |
| SSRI/Serotonin/SNRI + placebo | PLACEBO_COMPARATOR | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + placebo BID |
| SSRI/Serotonin/SNRI+ TC-5214 0.5 mg | EXPERIMENTAL | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID |
| SSRI/Serotonin/SNRI + TC-5214 2 mg | EXPERIMENTAL | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID |
| SSRI/Serotonin/SNRI + TC-5214 4 mg | EXPERIMENTAL | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID |
| 1 | EXPERIMENTAL | TC-5214 |
| 2 | PLACEBO_COMPARATOR | Placebo matched to TC-5214 |
| Name | Type | Description |
|---|---|---|
| TC-5214 | DRUG | Tablet, oral, twice daily for 8 weeks |
| Placebo | DRUG | Tablet, oral, twice daily for 8 weeks |
Inclusion Criteria: * Provision of signed and dated informed consent before initiation of any study-related procedures. * The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant. * Out-patient status at enrollment and...
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TC-5214 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It has been studied as an adjunct therapy in patients with major depressive disorder and in elderly subjects 65 years and older. It is not currently listed as an approved product and remains in clinical development.
TC-5214 was studied as an adjunct therapy in patients with major depressive disorder, meaning it was tested alongside another antidepressant rather than as a standalone treatment. Trials enrolled adults 18 years and older across North America, South America, Europe, and India. The program is not currently active.
TC-5214 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical trial program for the compound, including Phase 1 work in elderly subjects and Phase 3 studies in major depressive disorder.
TC-5214 is at Phase 1 in its current development listing, and it is investigational rather than an approved medicine. Five trials have been completed and none are active. The completed program includes one Phase 1 study and three Phase 3 studies in major depressive disorder.
Five completed trials are registered for TC-5214, with no active studies. These include NCT01239771, a Phase 1 safety and pharmacokinetic study in 32 medically stable elderly subjects in Sweden, and three Phase 3 adjunct-therapy trials in major depressive disorder: NCT01197508 with 696 patients, NCT01180400 with 295 patients, and NCT01157078 with 319 patients.
Across the five completed trials, 4,532 participants were enrolled. The studies were randomized, double blind, and placebo controlled. The largest was NCT01197508, a Phase 3 adjunct-therapy trial in major depressive disorder that enrolled 696 patients across 17 countries.