A Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety of REL-1017 as a Treatment of Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 627
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This was a 1-year, multicenter, open-label, long-term study to assess the safety of REL-1017 once daily (QD) as monotherapy or as adjunctive treatment of Major Depressive Disorder. Adjunctive study participants continued to take their current antidepressant therapy in addition to the study drug for the duration of the treatment period.
详细描述
This was a multicenter, open-label, long-term study of REL-1017 to evaluate the long-term safety and long-term durability of response in patients with MDD. Patients who completed previous randomized, double-blind Phase 3 trials (NCT04688164, NCT04855747, NCT05081167) of REL-1017 as adjunctive therapy or monotherapy for MDD were asked to continue treatment with REL-1017 25 mg daily for up to 1 year. De novo patients who satisfied inclusion/exclusion criteria also were enrolled and received a 75 mg loading dose of REL-1017 on Day 1 followed by a maintenance dose of 25 mg REL-1017 daily for the remainder of the study (Days 2-365). When REL-1017 was administered as adjunctive treatment, patients continued to use a stable dosage of their concomitant antidepressants.
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
- •Adults 18 to 65 years, inclusive.
- •Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
- •Current major depressive episode.
排除标准
- •Any current and primary psychiatric disorder other than Major Depressive Disorder.
- •History of bipolar I and II disorder, psychosis, and/or mania.
- •Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
研究组 & 干预措施
REL-1017
Roll-over participants received 25 mg REL-1017 (one 25 mg REL-1017 tablet), orally, per day, either as a monotherapy or in addition to their ongoing antidepressant (ADT), rolling over from the monotherapy study REL-1017-303 or the adjunctive therapy studies REL-1017-301 and REL-1017-302, respectively.
De Novo participants received a 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) on Day-1 of the 365-day treatment period. From Day-2 to Day-365, participants received 25 mg REL-1017 either as monotherapy or as adjunctive therapy.
干预措施: REL-1017 (Drug)
结局指标
主要结局
Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs)
时间窗: 52 weeks
Subjects with at least one Treatment Emergent Adverse Events (TEAEs)
次要结局
- Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 3(3 Month)
- Change in Diastolic Blood Pressure From Baseline to Month 3(3 Month)
- Change in Weight From Baseline to Month 3(3 Month)
- Change in Weight From Baseline to Month 12(12 Month)
- Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 6(6 Month)
- Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 12(12 Month)
- Change in Systolic Blood Pressure From Baseline to Month 3(3 Month)
- Change in Systolic Blood Pressure From Baseline to Month 12(12 Month)
- Change in Heart Rate From Baseline to Month 3(3 Month)
- Change in Heart Rate From Baseline to Month 12(12 Month)
- Change in Diastolic Blood Pressure From Baseline to Month 12(12 Month)