NCT02085135已完成3 期
A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Number of Subjects With Adverse Events (AEs)
研究概览
简要总结
This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index of 18-40 kg/m2
- •Have a diagnosis of MDD
- •Have a current major depressive episode (MDE) lasting 8 weeks to 24 months
- •Have been treated with an adequate dose of an approved antidepressant during the current MDE for at least 8 weeks
- •Have an inadequate response to current antidepressant treatment
- •Agree to use an approved method of birth control for the duration of the study
- •Additional criteria may apply
排除标准
- •Currently pregnant or breastfeeding
- •History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
- •Have experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
- •Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
- •Have received electroconvulsive therapy treatment within the last 5 years
- •Have attempted suicide within the past 2 years
- •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 with 60 days of screening
- •Additional criteria may apply
研究组 & 干预措施
Titration Schedule 1
Experimental
干预措施: ALKS 5461 (Drug)
Titration Schedule 2
Experimental
干预措施: ALKS 5461 (Drug)
结局指标
主要结局
Number of Subjects With Adverse Events (AEs)
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)Pneumococcal DiseaseNCT05569954Merck Sharp & Dohme LLC1,484
已完成
3 期
Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)Pneumococcal DiseaseNCT05633992Merck Sharp & Dohme LLC450
已完成
3 期
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)Pneumococcal InfectionNCT05425732Merck Sharp & Dohme LLC2,663
已完成
3 期
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease PatientsNon-Alcoholic Fatty Liver DiseaseNCT04197479Madrigal Pharmaceuticals, Inc.1,343
已完成
3 期
Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent PatientsGastroesophageal Reflux Disease (GERD)NCT00241501AstraZeneca140