A Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients With Cancer and Other Medical Illnesses
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 49
- 主要终点
- RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
研究概览
简要总结
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a ≥4 week history of AjD as defined by DSM-5-TR with either depressed mood, or mixed anxiety and depressed mood confirmed by clinical interview with evidence that the AjD was instigated by one of the following medical illnesses (e.g., diagnosis, impact, management, recurrence, prognosis): Cancer, ALS, MS, PD or IPF
- •Is sufficiently ambulatory and capable of self care as necessary to complete study procedures
- •Has normal cognitive function
- •Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study
- •If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant
- •Is willing and able to comply with the conditions and requirements of the study
排除标准
- •Has a significant risk of suicide
- •Has active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder
- •Has active or a history of central nervous system malignancy
- •Has other medically significant conditions rendering unsuitability for the study
- •Has used or will need to use prohibited medications or therapies
- •Has a known sensitivity or intolerance to study intervention or potential rescue medications
研究组 & 干预措施
1.5 mg RE104
A single subcutaneous injection of 1.5 mg RE104 for Injection
干预措施: RE104 for Injection (Drug)
30 mg RE104
A single subcutaneous injection of 30 mg RE104 for Injection
干预措施: RE104 for Injection (Drug)
结局指标
主要结局
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
时间窗: Day 7
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression.
次要结局
- RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)(Day 7)
- RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.(From dosing through study completion (post-dose follow-up is for 42 days))