Efficacy and Safety of Fixed doses of BMS 820836 in the Treatment of Patients with Treatment Resistant Major Depression

INTERVENTION: Product Name: Triple Reuptake Inhibitor Product Code: BMS‐820836‐03 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Triple Reuptake Inhibitor Current Sponsor code: BMS‐820836‐03 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .25‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Triple Reuptake Inhibitor Product Code: BMS‐820836‐03 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Triple Reuptake Inhibitor Current Sponsor code: BMS‐820836‐03 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Triple Reuptake Inhibitor Product Code: BMS‐820836‐03 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Triple Reuptake Inhibitor Current Sponsor code: BMS‐820836‐03 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: CYMBALTA*28CPS GASTROR 30MG Pharmaceutical Form: Capsule INN or Proposed INN: DULOXETINE HYDROCHLORIDE CAS Number: 136434‐34‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: CIPRALEX*CONT 100CPR RIV 10MG Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: ESCITALOPRAM OXALATE CAS Number: 219861‐08‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: Subjects with Treatment Resistant Major Depression ; MedDRA version: 14.1 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 ‐ Psychiatric disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: The purpose of the study is to evaluate the efficacy of study drug (BMS‐; 820836) as compared with continued duloxetine/escitalopram in the; treatment of patients with treatment resistant depression (TRD). Primary end point(s): Change from baseline to enpoint in the MADRS total score Secondary Objective: Change from baseline to endpoint in mean Sheehan Disability Scale; (SDS) score. Timepoint(s) of evaluation of this end point: Week 13 SECONDARY OUTCOME: Secondary end point(s): Change from baseline to endpoint in mean Sheehan Disability Scale ; (SDS) score. Timepoint(s) of evaluation of this end point: week 13 INCLUSION CRITERIA: a) Patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use. b) Patients with a diagnosis of Major Depressive Disorder, currently experiencing a Major Depressive Episode, as defined by DSM IV TR criteria. The current depressive episode must be > 8 weeks in duration and < 3 years duration; c) In the current MDD episode, patients should report a history of inadequate response to 1 3 adequate trials of antidepressant treatment. d) Patients must have a HAM‐D17 total score >= 18 at Screening; Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range