临床试验/NCT03610048

NCT03610048终止3 期

A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder

Alkermes, Inc.1 个研究点分布在 1 个国家目标入组 175 人开始时间: 2018年8月9日最近更新: 2021年7月16日

适应症

干预措施

试验速览

阶段: 3 期
状态: 终止
发起方: Alkermes, Inc.
入组人数: 175
试验地点: 1
主要终点: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

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

This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 72 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Completed study ALK5461-217
•Be willing to abide by the contraception requirements as outlined in the study protocol
•Be willing and able to follow the study procedures and visits as outlined in the protocol
•Additional criteria may apply

排除标准

•Pregnant, planning to become pregnant, or breastfeeding
•A positive urine drug test for drugs of abuse
•Poses a current suicide risk
•Additional criteria may apply

研究组 & 干预措施

ALKS 5461

Experimental

Sublingual tablets

干预措施: ALKS 5461 (Drug)

结局指标

主要结局

Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

时间窗: Up to 68 weeks

Number and percentage of subjects experiencing TEAEs

次要结局

未报告次要终点

研究者

发起方

Alkermes, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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