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.
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