Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TC-5214 · 11 trials · 10 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 |
| A - first fed then fasted treatment | EXPERIMENTAL | TC-5214 |
| B - first fasted then fed treatment | EXPERIMENTAL | TC-5214 |
| 1 | EXPERIMENTAL | TC-5214 |
| 2 | PLACEBO_COMPARATOR | Placebo matched to TC-5214 |
| Active | EXPERIMENTAL | Each cohort will have 9 volunteers that will receive 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 being studied as an adjunct therapy in patients with major depressive disorder. It has also been evaluated in clinical trials involving healthy subjects and elderly subjects, including those with stable disease, to assess its safety, tolerability, and pharmacokinetics.
TC-5214 is being developed by AstraZeneca PLC, which is listed on the stock exchange under the ticker AZN. The company has sponsored multiple clinical trials to evaluate the drug's efficacy, safety, and pharmacokinetic profile across various patient populations.
TC-5214 has completed Phase 1 and Phase 3 clinical trials. The Phase 3 trial assessed its efficacy and safety as an adjunct therapy in major depressive disorder, while Phase 1 trials focused on pharmacokinetics in elderly subjects, subjects with renal impairment, and healthy subjects.
TC-5214 has been studied in several completed trials, including NCT01197508, a Phase 3 study in major depressive disorder with 696 participants, and NCT01239771, a Phase 1 study in elderly subjects. Other trials include NCT01240967 in renal impairment and NCT01458899 in healthy subjects.
TC-5214 is an investigational drug and is not FDA approved. It has completed clinical trials, including a Phase 3 study for major depressive disorder, but no approval status has been reported. The drug remains in clinical development as an investigational therapy.
TC-5214 is a small molecule, but its specific molecular target has not been disclosed in the available clinical trial information. The trials focus on its efficacy and safety in major depressive disorder and its pharmacokinetic properties in various populations.