A Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose Frequency Study of Ketamine in Subjects With Treatment-resistant Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15
研究概览
简要总结
The purpose of this study is to explore the optimal dose frequency of ketamine in patients with treatment-resistant depression (TRD).
详细描述
This is a double-blind (patients and study personnel do not know the identity of the administered treatments), randomized (the drug is assigned by chance), placebo-controlled (placebo is a substance that appears identical to the treatment and has no active ingredients), parallel arm study (each group of patients will be treated at the same time). The study will consist of a screening phase of up to 4 weeks, a 4-week double-blind treatment phase (Day 1 to Day 29), and a 3-week post treatment (follow up) phase. In the double-blind phase, patients will receive over 4 weeks either intravenous (IV) infusions of placebo (2 or 3 times weekly) or IV infusions of ketamine (2 or 3 times weekly). The total study duration for each patient will be a maximum of 13 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be medically stable on the basis of clinical laboratory tests performed at screening
- •Meet diagnostic criteria for recurrent major depressive disorder (MDD), without psychotic features
- •Have a history of inadequate response, ie treatment was not successful, to at least 1 antidepressant
- •Have an Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) total score >= 40 at screening and predose at Day 1
- •Inpatient or agreed to be admitted to the clinic on each dosing day
排除标准
- •Has uncontrolled hypertension
- •Has a history of, or current signs and symptoms of diseases, infections or conditions that in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
- •Has known allergies, hypersensitivity, or intolerance to ketamine or its excipients
- •Is unable to read and understand the consent forms and patient reported outcomes, complete study-related procedures, and/or communicate with the study staff
研究组 & 干预措施
Placebo 3 times/week
干预措施: Placebo (Drug)
Ketamine 3 times/week
干预措施: Ketamine (Drug)
Ketamine 2 times/week
干预措施: Ketamine (Drug)
Placebo 2 times/week
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15
时间窗: Baseline (Day 1) and Day 15
The MADRS 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 score of 60. Higher scores represent a more severe condition.
次要结局
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 29(Baseline (Day 1) and Day 29)
- Number of Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Day 15 and Day 29)
- Number of Remitters Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Day 15 and Day 29)
- Number of Sustained Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Day 15)
- Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Endpoint (Day 29)(Baseline (Day 1) and Endpoint (Day 29))
- Clinical Global Impression of Improvement (CGI-I) Score at Endpoint of Double Blind Phase(Endpoint (Day 29))
- Change in Patient Global Impression-Severity (PGI-S) Score From Baseline to Endpoint (Day 29)(Baseline (Day 1) and Endpoint (Day 29))
- Patient Global Impression-Change (PGI-C) Score at Endpoint of Double Blind Phase(Endpoint (Day 29))
- Maximum Observed Plasma Concentration (Cmax) of Ketamine(Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ketamine(Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15)
- Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last])(Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15)
- Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])(Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15)
- Total Systemic Clearance (CL) of Ketamine(Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15)
- Volume of Distribution at Steady-State (Vss) of Ketamine(Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15)
- Elimination Half-Life (t1/2)(Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15)