A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous MIJ821 Injection in Addition to Standard of Care in Participants With Treatment-resistant Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) After Injection
研究概览
简要总结
The main purpose of this study was to evaluate safety and efficacy of a single injection of MIJ821 in addition to standard of care (SoC) pharmacological anti-depressant treatment in participants with treatment-resistant depression (TRD)
详细描述
The trial included a screening period of up to 28 days. On Day 1, after screening, eligible participants were randomized to one of the treatment arms (1 mg, 4 mg, or 10 mg of MIJ821) or placebo and received study treatment administered as a single subcutaneous injection. Participants remained at the clinic for at least 4 hours after administration of study treatment for safety observation including assessment of local tolerability by visual inspection of the injection area. Post-dose clinic visits occurred 24 hours post dose (Day 2), Days 8, 15, 22 and 29 to evaluate efficacy and safety. Efficacy assessments included the Montgomery-Asberg Depression Scale (MADRS) and other clinical outcome assessments (COAs). Safety assessments included laboratory tests, ECGs, vital signs and physical examinations. In addition, phone calls were conducted 3 days after each on-site clinic visit with the exception of the End-of-study (EOS) visit. EOS visit was completed on site on Day 29. Including screening, participants were in the study for up to 8 weeks (57 days).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained prior to participation in the study
- •Male and female participants, 18 to 65 years of age (inclusive) at screening
- •DSM-5 defined major depressive disorder (MDD) and a current major depressive episode (MDE)
- •MADRS score ≥ 24
- •Failure to respond to 2 or more antidepressant treatments where the two failed treatments are two different antidepressants
排除标准
- •Any prior or current diagnosis of MDD with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder
- •Participants with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or participants who went through detoxification treatment within 1 month before Screening
- •Participants with current borderline personality disorder or antisocial personality disorder
- •Current clinical diagnosis of autism, dementia, or intellectual disability
研究组 & 干预措施
MIJ821 1 mg
Participants received a single dose of 1 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
干预措施: MIJ821 Subcutaneous Injection 1 mg (Drug)
MIJ821 4 mg
Participants received a single dose of 4 mg MIJ821 administered as an SC injection on Day 1.
干预措施: MIJ821 Subcutaneous Injection 4 mg (Drug)
MIJ821 10 mg
Participants received a single dose of 10 mg MIJ821 administered as an SC injection on Day 1.
干预措施: MIJ821 Subcutaneous Injection 10 mg (Drug)
Placebo
Participants received a single dose of 0.9% sodium chloride solution administered as an SC injection on Day 1.
干预措施: Placebo Subcutaneous Injection (Drug)
结局指标
主要结局
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) After Injection
时间窗: Baseline and 24 hours after SC injection
The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel.
次要结局
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)(From Day 1 after SC injection to end of study, up to 29 Days)
- Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameters: Placebo Effect E0, Emax(Baseline, Day 2, 15, 22 and 29)
- Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: EC50 (Cmax)(Baseline, Day 2, 15, 22 and 29)
- Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: EC50 (AUClast)(Baseline, Day 2, 15, 22 and 29)
- Pharmacokinetics (PK) of MIJ821 in Plasma for Area Under the Curve From the Time of Dosing to the Time of the Last Measurable Concentration (AUClast)(Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection)
- PK of MIJ821 in Plasma for Maximum Serum Concentration (Cmax)(Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection)
- Change From Baseline in the MADRS Total Scores at Day 8, 15, 22 and 29 Visits(Baseline, Days 8, 15, 22 and 29)
- Dose-response (DR) Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score at 24 Hours After Single SC Injection(Baseline up to 24 Hours)
- PK of MIJ821 in Plasma for Time to Maximum Drug Concentration (Tmax)(Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection)
- Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: Hill Parameter(Baseline, Day 2, 15, 22 and 29)