An Open-label, Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 617
- 试验地点
- 124
- 主要终点
- The Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
- •Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Screening
- •Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
- •If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.
排除标准
- •DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening
- •Lifetime history of meeting DSM-5 criteria for:
- •Schizophrenia spectrum or other psychotic disorder
- •Bipolar or related disorder
- •Major neurocognitive disorder
- •Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
- •Dissociative disorder
- •Posttraumatic stress disorder
- •MDD with psychotic features
- •Significant suicide risk, as judged by the Investigator.
研究组 & 干预措施
Rapastinel
Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks.
干预措施: Rapastinel (Drug)
结局指标
主要结局
The Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: 52 Weeks
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
次要结局
- Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+)(Baseline to 52 Weeks)
- Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS)(Baseline to 52 Weeks)