NCT01309945已完成2 期
A Multicenter, Randomized, Double-blind, Active-Controlled Study of the Efficacy and Safety of Flexibly-Dosed BMS-820836 in Patients With Treatment Resistant Major Depression
Bristol-Myers Squibb48 个研究点 分布在 2 个国家目标入组 889 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 889
- 试验地点
- 48
- 主要终点
- Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
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 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
- Double (Participant, Investigator)
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
- •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.
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 at an adequate dose and for an adequate duration in their current episode unless in the judgment of the investigator, the patient could benefit from the treatment with this medication.
- •Patients whose only inadequate response to an antidepressant in the current Major Depressive Episode (MDE) is to an Serotonin norepinephrine reuptake inhibitors (SNRI) (duloxetine, venlafaxine, desvenlafaxine or milnacipran).
研究组 & 干预措施
Arm 1: Duloxetine 30mg
Active Comparator
干预措施: Duloxetine (Drug)
Arm 2: BMS-820836 placebo
Placebo Comparator
干预措施: Placebo matching with BMS-820836 (Drug)
Arm 3: BMS-820836 0.5-2.0 mg/day
Experimental
干预措施: BMS-820836 (Drug)
Arm 4: Duloxetine 30mg
Active Comparator
干预措施: Duloxetine (Drug)
Arm 5: Duloxetine placebo
Placebo Comparator
干预措施: Placebo matching with Duloxetine (Drug)
结局指标
主要结局
Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
时间窗: End of phase B and End of phase C
次要结局
- Change in Sheehan Disability Scale (SDS) Total score(End of Phase B and End of Phase C)
- Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score(End of Phase B and End of Phase C)
研究者
研究点 (48)
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