A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD).

Bristol-Myers Squibb48 个研究点分布在 2 个国家目标入组 976 人开始时间: 2011年7月最近更新: 2015年10月12日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 976
试验地点: 48
主要终点: Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Men and women of age 18-65 years (Argentina minimum age will be 24 years of age)
•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.
•Patients with a diagnosis of Major Depressive Disorder, currently experiencing a Major Depressive Episode, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (Text Revision)[DSM IV TR] criteria. The current depressive episode must be > 8 weeks in duration and < 3 years duration.
•In the current Major depressive disorder (MDD) episode, patients should report a history of inadequate response to 1-3 adequate trials of antidepressant treatment.
•Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥ 18 at Screening and Baseline.

排除标准

•Patients who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three adequate trials of antidepressant treatments during the current depressive episode.
•Patients who have failed Duloxetine and Escitalopram at an adequate dose and for an adequate duration in their current episode.

研究组 & 干预措施

Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo

Active Comparator

干预措施: Duloxetine (Drug)

Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo

Active Comparator

干预措施: Escitalopram (Drug)