The Effect of Intravenous Ketamine on Non-suicidal Self-injuries in Women Suffering From Complex Post Traumatic Stress Disorder (cPTSD)
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical measures - non suicidal self injuries symptoms
研究概览
简要总结
Non-suicidal self-injuries (NSSI) is a deliberate harm a person causes directly to their body, resulting in structural or functional damage, without suicidal ideation. This behavior is related to unbearable internal stress, thoughts, or mental pain, which NSSI assists in dismantling. To date, there is no generally approved therapy that assists in lowering NSSI. Ketamine is a sedative drug, presently at the focus of psychopharmacologic research, which was found to improve depression, when taken orally, and lower suicidal ideation, when given intravenously. Our aim is to assess the efficiency of intravenous ketamine in decreasing NSSI symptomology in women with a history of childhood sexual abuse presenting with such behavior. Participants will be recruited among hospitalized patients from the Tel-Aviv Medical Central psychiatric ward, who will present with either NSSI urges or behavior. The study design is a randomized control, double blind trial. Each patient will be assessed before, during, and after the trial by physical examination, blood tests and questionnaires. The patients will be randomized into research group (treated by ketamine and midazolam intravenously) or control group (treated intravenously via midazolam only). Our hypothesis is that treatment by intravenous ketamine will lower NSSI symptomology, and enable optimal treatment while being hospitalized.
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)
盲法说明
Blinded participants and investigator.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 y.o.
- •Hospitalized
- •Willing to sign the informed consent
- •Fluent in Hebrew
- •Reporting unbearable urge for self-injury and / or active NSSI behaviour) upon admittance, or on the preceding week.
- •Not pregnant, nor breast feeding
- •No history of drugs abuse
- •No previous treatment with ketamine
- •No psychotic disorder, nor severe physical condition (including unstable hypertension, arrhythmias or severe / active neurological condition)
排除标准
- •Age < 18 year; Age >65 years
- •Inability to sign informed consent, Non-Fluent in Hebrew.
- •No report of NSSI, last NSSI event took place further than preceding week
- •Active pregnancy or breast feeding
- •History of drugs abuse
- •Previous trial involving ketamine treatment during which no improvement was observed.
- •Presence of psychotic disorder, and / or major physical condition (including unstable hypertension, arrhythmias or severe / active neurological condition).
研究组 & 干预措施
Research: Ketamine + Midazolam
Research group will receive ketamine and midazolam.
干预措施: Ketamine (Drug)
Research: Ketamine + Midazolam
Research group will receive ketamine and midazolam.
干预措施: Midazolam (Drug)
Control: Midazolam
Control group will receive midazolam.
干预措施: Midazolam (Drug)
结局指标
主要结局
Clinical measures - non suicidal self injuries symptoms
时间窗: Four days prior to 1st treatment; after each intervention: 1 hour, 4 hours, 24 hours; next intervention will take place 3 days after (4 interventions altogether); 3 weeks post last intervention.
Change in non suicidal self injuries symptoms will be measured by Brief Non-Suicidal Self-Injury Assessment (BNSSI), which assess the quality of self injuries (method of injury, time since last injury, causes of injury, motivation of self injury and bodily areas where injuries are most common).
次要结局
- Clinical measures - biomarkers related to ketamine treatment - hsCRP(Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.)
- Self reported questionnaires - Suicidal ideation(SSI will be taken four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.)
- Self reported questionnaires - impulsivity(BIS-11 will be taken four days prior to 1st treatment four days; 3 weeks post last intervention.)
- Clinical measures - biomarkers related to ketamine treatment - BDNF(Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.)
- Self reported questionnaires - Visual Analogue Scale (VAS)(VAS will be after each intervention: 1 hour, 4 hours, 24 hours; next intervention will take place 3 days after (4 interventions altogether).)
- Clinical measures - adverse effects(Adverse effects questionnaire will be taken after each intervention: 1 hour, 4 hours; next intervention will take place 3 days after (4 interventions altogether).)
- Clinical measures - biomarkers related to ketamine treatment - IL-6(Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.)
- Self reported questionnaires - depressive symptoms(BDI will be taken four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.)
- Self reported questionnaires - anxiety symptoms(DASS-21 will be taken four days prior to 1st treatment; 3 weeks post last intervention.)
- Self reported questionnaires - well being(WHO-5 will be taken four days prior to 1st treatment; 4 hour after 2nd intervention; 7 days later, 4 hour after 4th intervention; 3 weeks post last intervention.)