Conditions: Major Depressive Disorder Depression
Keywords: Major Depressive Disorder MDD Depression Safety add-on therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 295
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 together with another antidepressant.

Detailed description:
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant 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, 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 8 weeks intervention 2: Tablet, oral, twice daily for 8 weeks

Protocol document: