Double-Blind Randomized Controlled Trial of Acute-Course of Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents

氯胺酮与咪达唑仑治疗青少年自杀复发急性病程的双盲随机对照试验

• 批准号: 10114915
• 负责人: MADHUKAR H. TRIVEDI
• 金额: $ 62.03万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10114915
• 关键词: Accident and Emergency department; Acute; Adolescent; Adult; Age; Age-Years; Caregivers; Caring; Cause of Death; Clinical; Clinical Trials; Cognition; Cognitive; Development; Double-Blind Method; Emergency department visit; Event; Family; Feeling suicidal; Female; Goals; Grant; Hospitalization; Hour; Implicit Association Test; Individual; Infusion procedures; Inpatients; Intervention; Interview; Intravenous; Ketamine; Knowledge; Length of Stay; Link; Measures; Mediating; Mediation; Medical; Medicine; Mental Depression; Midazolam; Participant; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Pharmacotherapy; Placebos; Provider; Psychotherapy; Randomized; Randomized Controlled Trials; Recurrence; Reporting; Research; Risk; Suicide; Suicide attempt; Testing; Time; Visit; Youth; aged; associated symptom; base; care seeking; clinical care; depressive symptoms; effectiveness trial; enantiomer; experience; experimental study; high risk; innovation; male; novel therapeutics; open label; outpatient programs; prevent; programs; recruit; reduce symptoms; standard care; standard of care; suicidal; suicidal adolescent; suicidal behavior; suicidal morbidity; suicidal risk; suicide rate; symptomatic improvement; treatment duration

PROJECT SUMMARY Rates of suicide have increased dramatically in youths over the past decade, and suicide is now the 2nd leading cause of death for individuals ages 15-24. There are no validated treatments to decrease the risk of adolescent suicidal behavior, and currently available standard treatments are of modest benefit and often take weeks or months to become effective. Hence, there is an urgent need to identify rapid-acting treatments that ameliorate symptoms associated with suicidality and prevent repeat suicidal events. Based on evidence for efficacy of ketamine in reducing symptoms of suicidality in adults, as well as an open label study in adolescents, ketamine appears to be a promising treatment approach for youths with a recent suicidal event. We propose to conduct the first randomized, controlled trial of ketamine in youth with recent suicidal behaviors. All youth will be in treatment in an intensive outpatient program for suicidal adolescents, and will be randomized to intravenous ketamine 0.5mg/kg or midazolam 0.02mg/kg for four infusions over two weeks within +/- ten days of starting IOP. We will also examine implicit cognitive associations using the Death/Suicide Implicit Association Test (IAT). All participants will be followed for 12 weeks to evaluate: 1) reduction in repeat suicide attempts over 12 weeks, 2) reduction in implicit suicidal cognition within the 2-week study treatment period, and 3) reduction in depression and suicidal ideation within the 2-week study period. We will also explore whether reductions in IAT mediates improvement in suicidality over 12 weeks. To date, no study has reported evidence for 1) reduction in repeat suicidal events with ketamine either in adults or in youths (AIM 1), 2) reductions either in implicit cognition (AIM 2) or in symptoms associated with suicidality (AIM 3) in youths, and 3) underlying mechanisms that mediate (AIM 4) the effects of ketamine on suicidality. Innovative features include: 1) it targets repeat suicidal events during a high-risk period in high-risk youths who are typically excluded from clinical trials; 2) is transdiagnostic; 3) seamlessly integrates in current standard of care; and 4) evaluates an intervention that can be delivered at a time and place when there is greatest clinical need, but for which there are no currently developed interventions.