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Treatment For Adolescents With Depression Study (Tads): Safety Results., Graham Emslie, Christopher J. Kratochvil, Benedetto Vitiello, Susan Silva, Taryn Mayes, Steven Mcnulty, Elizabeth Weller, Bruce Waslick, Charles Casat, John Walkup, Sanjeev Pathak, Paul Rohde, Kelly Posner, John March, The Columbia Suicidality Classification Group, Tads Team

Journal Articles: Psychiatry

OBJECTIVE: To compare the rates of physical, psychiatric, and suicide-related events in adolescents with MDD treated with fluoxetine alone (FLX), cognitive-behavioral therapy (CBT), combination treatment (COMB), or placebo (PBO).

METHOD: Safety assessments included adverse events (AEs) collected by spontaneous report, as well as systematic measures for specific physical and psychiatric symptoms. Suicidal ideation and suicidal behavior were systematically assessed by self- and clinician reports. Suicidal events were also reanalyzed by the Columbia Group and expert raters using the Columbia-Classification Algorithm for Suicidal Assessment used in the U.S. Food and Drug Administration reclassification effort.

RESULTS: Depressed adolescents reported high rates of …