Conditions: Major Depressive Disorder MDD Depression
Keywords: Major Depressive Disorder MDD Depression Safety add-on therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 813
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken for 52 weeks with another antidepressant medicine.

Detailed description:

Arms:
arm 1: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 mg BID arm 2: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + placebo BID

Interventions: intervention 1: TC-5214 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet, oral, twice daily for 52 weeks intervention 2: Tablet, oral, twice daily for 52 weeks

Protocol document: