A Longitudinal Observational Cohort Study of NSI-189, a Neurogenic Compound Among Out-Patients With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 主要终点
- Primary Objective: Durability of Effect defined as the time until the start of a new antidepressant treatment (ADT)
研究概览
简要总结
All subjects completing the randomized treatment period in Protocol NS2014-1 will discontinue study drug and be asked to provide consent to be followed in this 6-month study, at their final safety visit. The study will consist of an enrollment visit, followed by bi-monthly in-clinic visits with monthly telephone visits between in-clinic visits.
详细描述
Following completion of the NS2014-1 final study visit procedures, Subjects will be offered the opportunity to enroll in this longitudinal observational cohort protocol to monitor their depression and to assess durability of effect and long-term safety of NSI-189.
The Enrollment Visit begins when informed consent is signed.The duration of the follow-up period will be up to 6 months, until the start of a new antidepressant treatment. Subjects who provide consent will be seen for in-person visits every 8 weeks, with bi-monthly phone visits occurring between in-person visits. Safety assessments and efficacy assessments will be performed at each visit. No study drug will be taken during the Longitudinal Observational Cohort study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has the ability to understand the purpose, potential benefits and risks of the study and to provide signed and dated informed consent, authorizing the use of protected health information in accordance with national and local Subject privacy regulations.
- •Subject completed the 12-week randomized treatment period and final study visit for the NS2014-1 clinical study.
排除标准
- •Subjects taking excluded medications.
- •Subject who, in the opinion of the Site Investigator, are unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study.
- •Subject who, in the opinion of the Site Investigator, are unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up and improbability of completing the clinical study.
研究组 & 干预措施
Longitudinal Observational Cohort
Following completion of the NS2014-1 final study visit procedures, Subjects will be offered the opportunity to enroll in this longitudinal observational cohort protocol to monitor their depression and to assess durability of effect and long-term safety of NSI-189.
干预措施: NSI-189 (Drug)
结局指标
主要结局
Primary Objective: Durability of Effect defined as the time until the start of a new antidepressant treatment (ADT)
时间窗: 6 months
The primary objective is to determine the durability of effect of NSI-189 phosphate compared to placebo in subjects with Major Depressive Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5TH EDITION). Durability of effect is defined as the time until the start of a new antidepressant treatment (ADT).
次要结局
- Montgomery-Asberg Depression Rating Scale (MADRS)(6 months)
- Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR)(6 months)
- Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH CPFQ)(6 months)
- 17-item Hamilton Depression Rating Scale (HAMD17)(6 months)
- Discontinuation rates(6 months)
- Cogscreen Battery(6 months)
- Symptoms of Depression Questionnaire (SDQ)(6 months)
- Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI)(6 months)
- The Columbia Suicide Severity Rating Scale (C-SSRS)(6 months)