NCT02400346已完成3 期
Interventional, Open-label, Flexible-dose, Long-term Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 34
- 主要终点
- Number of Patients With Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• The patient is a man or woman aged ≥65 yrs
- •The patient has Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™).
- •The patient has an inadequate response to at least one adequate antidepressant treatment in the current Major Depressive Episode (MDE).
- •The patient has had the current MDE for ≥8 weeks
- •The patient is currently treated with a protocol specified ADT for at least 6 weeks
- •The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
- •Montgomery and Åsberg Depression Rating Scale (MADRS) total score > 18 at screening and baseline
- •Clinical Global Impression - Severity (CGI-S) total score ≥3 at screening and baseline
排除标准
- •• The patient has a clinically significant unstable illness
- •The patient has newly diagnosed or unstable diabetes
- •The patient has a Mini Mental State Exam (MMSE) score <24
- •The patient has received Transcranial Magnetic Stimulation (TMS) and/or electroconvulsive therapy (ECT) less than 6 months prior to the Screening.
- •The patient, in the opinion of the investigator or based on Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation and behaviour rating, is at significant risk of suicide
- •Other protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Adjunct brexpiprazole
Experimental
All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition
干预措施: Adjunct brexpiprazole (Drug)
Adjunct brexpiprazole
Experimental
All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition
干预措施: ADT (Drug)
结局指标
主要结局
Number of Patients With Treatment-Emergent Adverse Events
时间窗: Baseline to 30 weeks
Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit
次要结局
未报告次要终点
研究者
研究点 (34)
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