EUCTR2014-000379-14-DE进行中（未招募）1 期
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the AdjunctiveTreatment of Major Depressive Disorder (the FORWARD-5 Study)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 470
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m^2, inclusive
- •Agree to use an acceptable method of contraception for the duration of
- •Have a Major Depressive Disorder (MDD) primary diagnosis
- •Have no more than 2 inadequate responses to antidepressant therapy
- •(ADT) in the current Major Depressive Episode (MDE)
- •Additional criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 446
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Have a current primary Axis-I disorder other than MDD
- •Have used opioid agonists (eg, codeine, oxycodone, tramadol,
- •morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14
- •Have received electroconvulsive therapy treatment within the last 2
- •years or received more than one course of electroconvulsive treatment
- •during lifetime
- •Have attempted suicide within the past 2 years
- •Have a positive test for drugs of abuse
- •Are pregnant, planning to become pregnant, or breastfeeding
- •Have a history of intolerance, allergy, or hypersensitivity to
- •buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
- •Have had a significant blood loss or blood donation within 60 days
- •Additional criteria may apply
研究者
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