OBJECTIVE: The purpose of this article is to describe the effects of the pediatric antidepressant controversy on the Treatment of Serotonin-Selective Reuptake Inhibitor (SSRI) Resistant Depression in Adolescents (TORDIA) trial. METHOD: Adolescents, ages 12-18 years, with SSRI resistant depression were randomized to one of four treatments for a 12 week trial: Switch to different SSRI, switch to an alternate antidepressant (venlafaxine), switch to an alternate SSRI plus cognitive behavior therapy (CBT), or switch to venlafaxine plus CBT. RESULTS: The health advisories and "black box" warnings regarding suicidality and antidepressants in adolescents occurred during the course of the TORDIA trial. Revisions to the protocol, multiple-consent form changes, and re-consenting of patients were necessary. Recruitment of participants was adversely affected. CONCLUSION: Despite a cascade of unforeseen events that delayed the completion of the study, the TORDIA trial resulted in clinically important information about treatment-resistant depression in adolescents.
RCT Entities:
OBJECTIVE: The purpose of this article is to describe the effects of the pediatric antidepressant controversy on the Treatment of Serotonin-Selective Reuptake Inhibitor (SSRI) Resistant Depression in Adolescents (TORDIA) trial. METHOD: Adolescents, ages 12-18 years, with SSRI resistant depression were randomized to one of four treatments for a 12 week trial: Switch to different SSRI, switch to an alternate antidepressant (venlafaxine), switch to an alternate SSRI plus cognitive behavior therapy (CBT), or switch to venlafaxine plus CBT. RESULTS: The health advisories and "black box" warnings regarding suicidality and antidepressants in adolescents occurred during the course of the TORDIA trial. Revisions to the protocol, multiple-consent form changes, and re-consenting of patients were necessary. Recruitment of participants was adversely affected. CONCLUSION: Despite a cascade of unforeseen events that delayed the completion of the study, the TORDIA trial resulted in clinically important information about treatment-resistant depression in adolescents.
Authors: Dara J Sakolsky; James M Perel; Graham J Emslie; Gregory N Clarke; Karen Dineen Wagner; Benedetto Vitiello; Martin B Keller; Boris Birmaher; Joan Rosenbaum Asarnow; Neal D Ryan; James T McCracken; Michael J Strober; Satish Iyengar; Giovanna Porta; David A Brent Journal: J Clin Psychopharmacol Date: 2011-02 Impact factor: 3.153
Authors: Frances L Lynch; John F Dickerson; Greg Clarke; Benedetto Vitiello; Giovanna Porta; Karen D Wagner; Graham Emslie; Joan Rosenbaum Asarnow; Martin B Keller; Boris Birmaher; Neal D Ryan; Betsy Kennard; Taryn Mayes; Lynn DeBar; James T McCracken; Michael Strober; Robert L Suddath; Anthony Spirito; Matthew Onorato; Jamie Zelazny; Satish Iyengar; David Brent Journal: Arch Gen Psychiatry Date: 2011-03
Authors: David A Brent; Graham J Emslie; Greg N Clarke; Joan Asarnow; Anthony Spirito; Louise Ritz; Benedetto Vitiello; Satish Iyengar; Boris Birmaher; Neal D Ryan; Jamie Zelazny; Matthew Onorato; Betsy Kennard; Taryn L Mayes; Lynn L Debar; James T McCracken; Michael Strober; Robert Suddath; Henrietta Leonard; Giovanna Porta; Martin B Keller Journal: Am J Psychiatry Date: 2009-02-17 Impact factor: 18.112