A Single Ketamine Infusion Combined With Music for Suicidal Ideation During a Depressive Episode: A Randomized Open Label Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Scale for Suicide Ideation (SSI)
研究概览
简要总结
Suicidal ideation (SI) associated with major and bipolar depression is commonly seen in a wide range of clinical practice situations including the emergency room (ER). Current treatment regimens are often unsatisfactory. About a third of patients fail to respond to currently available therapy, and there are no currently FDA indicated rapid acting treatments for SI. Suboptimal outcomes have triggered the search for new, well-tolerated and more effective forms of treatment. Small clinical trials suggest that low dose (0.5mg/kg) ketamine is safe and effective for SI. We believe adding music during ketamine infusion may reduce anxiety and lead to more reduced SI based on available evidence. We are testing the hypothesis that a single infusion of ketamine combined with music enhances tolerability and improves outcomes in the treatment of SI when combined with treatment as usual in a factorial study design. One treatment with Ketamine + music will be compared to compared to one-time treatment with ketamine alone, music alone, or treatment as usual. 50 individuals with a depressive episode and suicidal ideation will receive intravenous (IV) ketamine 0.5mg/kg infused over 40 minutes once with 60 minutes of music, 50 individuals will receive IV ketamine without music, 50 subjects will receive 60 minutes of music once, and 50 patients will receive treatment as usual without ketamine or music. We anticipate that the ketamine + music group will have statistically significant indices of improvement in the primary outcome, suicidal ideation scores on the Scale for Suicidal Ideation (SSI) 4 weeks after the ketamine infusion. Secondary outcomes will include depression scores on the MontgomeryÅsberg Depression Rating Scale (MADRS) scale, adverse effects, and SSI scores at the end of 4 weeks. If, as we anticipate, the results indicate success of ketamine + music for SI, the work will identify new opportunities to more effectively manage patients with depression and suicidal ideation presenting to the ER.
详细描述
Ketamine is a glutamate N-methyl-D-aspartate (NMDA) receptor antagonist traditionally used as a general anesthetic. Recent double blinded randomized control trials of intravenous (IV) ketamine infusions have been well-tolerated and demonstrated a rapid onset of antidepressant effect, most notably in subjects with treatment-resistant depression (TRD) and treatment-resistant bipolar depression.
Significance. The outcomes of current therapy for depression are poor, with roughly a third of patient's failing to improve or regressing. The patients are high risk for suicide and the need for rapid acting, durable treatments for reduction of suicidal ideation is paramount.
Ketamine has been shown to improve suicidal ideation for at least 6 weeks in the largest study of ketamine for SI to date in subjects recruited to participate in the clinical trial and admitted to a research facility. We intend to test ketamine in a more pragmatic trial in the ER in patients who are not actively recruited, but report SI to ER staff or have SI as a chief complaint.
Research Aims.
Overview. In the current open label randomized control trial, we will examine the suicidal ideation reducing efficacy of IV ketamine combined with music and treatment as usual in four groups. All four groups will receive treatment as usual as defined above (potential hospitalization, medication, psychotherapy, outpatient referrals, suicide safety planning). A factorial design is being implemented to test two interventions independently and combined: ketamine and music. One group will receive IV ketamine 0.5mg/kg infused over forty minutes with one hour of pre-planned music will be compared to 3 other groups: One group will receive the same dose of ketamine without music, one group will one hour of music without ketamine, and one group will receive neither music nor ketamine. During the 4-week follow up interval, subjects from both groups will be contacted by phone for weekly assessment of depression, SI and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults age 18-64
- •DSM-IV diagnosis of depressive episode as determined by the Mini International neuropsychiatric Interview criteria, and Montgomery Asberg Depression Rating Scale ≥ 28
- •Suicidal ideation at baseline as and positive suicidal ideation defined as Scale for Suicidal Ideation score ≥
- •Diagnosis of Major depressive disorder, bipolar disorder, or substance induced mood disorder will be included.
排除标准
- •Active psychotic symptoms
- •Current manic episode
- •Previous diagnosis of Schizophrenia or Schizoaffective disorder
- •Previous diagnosis of Intellectual disability or Autism Spectrum Disorder
- •Previous diagnosis of Major Neurocognitive Disorder
- •History of ketamine abuse or dependence
- •Hypersensitivity to esketamine, ketamine, or any of the excipients.
- •Uncontrolled clinically significant medical conditions such as:
- •Respiratory illness requiring the use of oxygen
- •Previously documented prolonged QTc interval
- •Current Aneurysmal vascular disease
- •Arteriovenous malformation
- •Intracerebral hemorrhage
- •Unstable cardiac disease including history of myocardial infarction
- •Positive urine pregnancy test
- •Previous treatment of depression with Ketamine or Esketamine
研究组 & 干预措施
Ketamine
One group will receive IV ketamine 0.5mg/kg infused over forty minutes
干预措施: Ketamine Hydrochloride (Drug)
Ketamine + Music
One group will receive IV ketamine 0.5mg/kg infused over forty minutes with one hour of pre-planned music
干预措施: Ketamine Hydrochloride (Drug)
Ketamine + Music
One group will receive IV ketamine 0.5mg/kg infused over forty minutes with one hour of pre-planned music
干预措施: Music (Other)
Music
One hour of pre-planned music without ketamine
干预措施: Music (Other)
结局指标
主要结局
Scale for Suicide Ideation (SSI)
时间窗: 4 weeks
Clinician administered scale. Score range 0-38. Higher scores are indicative of increased suicidal ideation. The primary efficacy evaluation for each panel will be the change in SSI total score from baseline, prior to the first IV ketamine dose, to 4 weeks after IV ketamine treatment. 25 % reduction in score will be deemed treatment response, 50% reduction will be determined to be treatment remission.
次要结局
- Time of hospitalization(4 weeks)
- Montgomery Asberg Depression Rating Scale (MADRS)(4 weeks)
- Quick Inventory of Depressive Symptomatology (QIDS SR-16)(4 weeks)
- World Health Organization Quality of life Scale (WHOQOL-BREF)(4 weeks)