Suicidality Risk Factors Across the CARE-HD, 2CARE, and CREST-E Clinical Trials in Huntington Disease

亨廷顿病 CARE-HD、2CARE 和 CREST-E 临床试验中的自杀风险因素

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Abstract

BACKGROUND AND OBJECTIVES: Suicidality is a common concern in the routine care of persons with Huntington disease (HD) and for the many participants in HD clinical trials. In a previous analysis, we identified baseline and time-dependent factors associated with suicidal ideation and attempts from 2CARE, a large, randomized, double-blind clinical trial. METHODS: The present analysis extends our prior methodology to 2 other large interventional HD clinical trials, CARE-HD and CREST-E. RESULTS: We observed relationships across studies between suicidality events and prior suicidal ideation at baseline, antidepressant/anxiolytic use, chorea, increasing age, and several domains in the Unified Huntington Disease Rating Scale (UHDRS) Behavioral Assessment (depressed mood, low self-esteem, aggression, and active suicidality). DISCUSSION: These data may form the basis for a subscale of demographic and UHDRS items with the potential for prospectively identifying suicidality risk in HD clinics and clinical trials. TRIAL REGISTRATION INFORMATION: 2CARE and CREST are registered at clinicaltrials.gov. 2CARE NCT00608881, registered February 6, 2008; first enrollment March 2008. CREST-E NCT00712426, registered July 10, 2008; first enrollment September 2009. CARE-HD, not registered; first enrollment July 1997.

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