Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder, MDD, Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 696
Healthy volunteers: no

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

Detailed description:
A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Arms:
arm 1: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID arm 2: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID arm 3: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID arm 4: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID

Interventions: intervention 1: TC-5214 intervention 2: Placebo
Intervention descriptions: intervention 1: Twice daily for 8 weeks. intervention 2: Twice daily for 8 weeks.

Protocol document: