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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01180400 | A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder | PHASE3 | COMPLETED | 295 | — | — | Sep 1, 2010 | Sep 1, 2011 | Apr 11, 2014 | 66 | Czechia, Estonia +8 |
| NCT01197508 | A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder. | PHASE3 | COMPLETED | 696 | — | — | Sep 1, 2010 | Jan 1, 2012 | Apr 11, 2014 | 87 | Argentina, Brazil +15 |
| NCT01152554 | A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder | PHASE3 | COMPLETED | 813 | — | — | Jun 1, 2010 | Feb 1, 2012 | Apr 11, 2014 | 94 | United States, Puerto Rico |
| NCT01153347 | A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder | PHASE3 | COMPLETED | 2,409 | — | — | Jun 1, 2010 | Jan 1, 2012 | Apr 11, 2014 | 99 | United States, India +1 |
| NCT01157078 | A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD) | PHASE3 | COMPLETED | 319 | — | — | Jun 1, 2010 | Nov 1, 2011 | Apr 11, 2014 | 51 | United States, India |
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 |
| 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...