A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.

Official Title
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A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: TC-5214
* Drug: Duloxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug. Outpatient status at enrollment and randomization. Exclusion Criteria: Patients with a lifetime history of bipolar disorder; psychotic disorder or post-traumatic stress disorder. Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide. Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation. History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury. Pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>TC-5214, 1 mg BID | Drug: TC-5214<br>* Tablet, oral, twice daily for 8 weeks<br>|
| Experimental: 2<br>TC-5214, 4 mg BID | Drug: TC-5214<br>* Tablet, oral, twice daily for 8 weeks<br>|
| Active Comparator: 3<br>Duloxetine 60 mg Q Day | Drug: Duloxetine<br>* Capsule, oral, once daily<br>|
| Placebo Comparator: 4<br>Placebo | Drug: Placebo<br>* Tablet, oral, twice daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment | A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (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. | Randomization (Week 8) to end of treatment (Week 16) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, MDD, Monotherapy, Inadequate Response to Antidepressant Therapy