TREATMENT OF ADOLESCENT SUICIDE ATTEMPTERS (TASA)

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究旨在探讨不同治疗方式对青少年抑郁症自杀倾向的治疗效果。比较器为：1）医疗管理（MM），通常是选择性5-羟色胺再摄取抑制剂（SSRI），可能补充锂; 2）认知行为治疗（CBT）计划，最多22个疗程;或3）MM+CBT，为期6个月的治疗方案和一年的随访。共有120名目前患有DSM-IV重度抑郁发作或心境恶劣障碍，并且在过去45天内有自杀企图的青少年将被随机分配到3组。这项研究将有助于验证结果措施和监测程序，包括安全性。它还将有助于提供计划更大规模试验所需的组间标准化效应量估计值。主要终点为至首次发生自杀事件的时间。次要终点包括：自杀意念的严重程度，用Beck量表测量;自杀事件和意念的发生率和密度，用自杀严重程度评定量表测量;激越和自杀意念的发生率;抑郁症状的严重程度，用修订的儿童抑郁评定量表测量;以及（探索性目标）绝望、攻击性、冲动性、焦虑、家庭冲突和社会功能障碍的水平。其中一些评估是由一名独立评估员在干预期间每隔6周进行一次。心理治疗师将监测全身功能（临床评级，SAE）几乎每周，以及评估可能的药物毒性。没有一种治疗方法被证明对青少年有效。在成人中，任何单独治疗提供的最大益处最多为60%。药物和行为疗法的组合在治疗成人抑郁症中显示出协同作用。方法：这是一项多中心NIMH研究，PI在开发中发挥了作用。它包括一些“安全”功能，包括一个监察员，以保护脆弱的青少年和一个蒙面自杀评估委员会。有教育家庭成员减少自杀可能性的程序，以及处理自杀事件和死亡的程序。对精神药理学家和独立评估人员进行了培训。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a feasibility study of the comparative efficacy of different forms of therapy for depressed adolescent suicide attempters. The comparators are: 1) medical management (MM), typically an selective serotonin reuptake inhibitor (SSRI) with possible lithium supplementation; 2) a cognitive behavior therapy (CBT) program for up to 22 sessions; or 3) MM+CBT over a 6-month treatment regimen and a year follow-up. A total of 120 adolescents with a current DSM-IV Major Depressive Episode, or Dysthymic Disorder, and a suicide attempt within the past 45 days will be randomized to the 3 groups. The study will help validate outcome measures and monitoring procedures, including safety. It will also help provide between-group standardized effect size estimates needed to plan a larger trial. The primary endpoint will be the time to first occurrence of a suicidal event. Secondary endpoints include the following: the severity of suicidal ideation, measured by the Beck Scale; the rate and density of suicidal events and ideation, measured by the Suicide Severity Rating Scale; the rate of agitation and suicidal ideation; the severity of depressive symptoms, measured by the revised Child Depression Rating Scale; and (exploratory aims) the levels of hopelessness, aggression, impulsivity, anxiety, family conflict and social dysfunction. Some of these assessments are made by an independent evaluator at 6-week intervals during the interventions. A psychotherapist will monitor systemic functions (clinical rating, SAEs) virtually weekly, as well as assess possible drug toxicity. None of the proposed therapies have been shown to be effective in adolescents. In adults, the maximal benefit provided by any of the treatments alone is 60% at best. Combinations of drug and behavior therapy have shown synergy in the treatment of adult depressive disorders. Approach: This is a multicenter NIMH study which the PI played a role in developing. It includes a number of "safety" features, including an ombudsman to protect the vulnerable adolescent and a Masked Suicide Evaluation Board. There are procedures for educating family members to decrease suicide potential, and procedures for handling suicide events and deaths. There is training for psychopharmacologists and independent evaluators.