Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score
研究概览
简要总结
Postpartum depression is a non-psychotic major or minor depressive episode that occurs during pregnancy or within 12 months of post-partum period. The nature of symptoms is same as depressive episode characterized by depressed mood, anxiety, sleep difficulties, suicidal thoughts, tiredness and diminished interest in pleasurable activities. Severe maternal depression affects children by increasing the risk of emotional and behavioral and physical health problems and cognitive difficulties. Thus early screening and intervention is critical in reducing the negative impact of PND in the mother and child, family and the community.
The purpose of this study is to assess the safety, pharmacokinetics and antidepressant efficacy of sub-anesthetic dose of intravenous ketamine in perinatal depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects, ages 18-45 years
- •Experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery and with moderate or severe symptoms (>12 EPDS or >14 HAM-D).
- •No or partial response to adequate doses of SSRI medications to treat PND for longer than 6 weeks.
- •PND patients will be requested to maintain the stable dose of antidepressants while enrolled in the study trial.
- •Patients that can speak and read the English language, are able to understand the study procedures and sign the informed consent
排除标准
- •No current or past psychosis or severe personality disorder.
- •No current substance abuse or dependence.
- •No serious and imminent suicidal or homicidal risk.
- •No recent or history of major and unstable medical problems that affect brain anatomy, neurochemistry, or function.
- •Not diagnosed with cardiovascular disorders.
- •No increased risk of laryngospasm or active upper respiratory infections.
- •Not diagnosed with an intellectual disability or neurodegenerative diseases.
- •Mothers that are currently breastfeeding.
- •No current pregnancy.
研究组 & 干预措施
Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg
single intravenous infusion of Ketamine (0.5 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.2 mg/kg)
干预措施: Ketamine 0.5 mg/kg (Drug)
Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg
single intravenous infusion of Ketamine (0.5 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.2 mg/kg)
干预措施: Ketamine 0.2 mg/kg (Drug)
Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg
single intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg)
干预措施: Ketamine 0.5 mg/kg (Drug)
Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg
single intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg)
干预措施: Ketamine 0.2 mg/kg (Drug)
结局指标
主要结局
Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score
时间窗: baseline, 24 hours post-injection
The Hamilton Depression Rating Scale (HAM-D) score ranges from 0-53. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity of depressive symptoms. The value reported is the score at baseline minus the score 24 hours post-injection.
次要结局
- Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale(baseline, 24 hours post-injection)
- Number of Treatment-Emergent Adverse Events(24 hours post-injection)
- Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale(baseline, 24 hours post-injection)
- Change in Depression as Indicated by Patient Health Questionnaire (PHQ-9)(baseline, 24 hours post-injection)
- Change in Behavioral Suicidal Events (Suicidal Ideation), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)(baseline, 24 hours post-injection)
- Change in Behavioral Suicidal Events (Suicidal Behavior), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)(baseline, 24 hours post-injection)
研究者
Sudhakar Selvaraj
Assistant Professor
The University of Texas Health Science Center, Houston