Out of the black box: Treatment of resistant depression in adolescents and the antidepressant controversy

Karen Dineen Wagner, Joan Rosenbaum Asarnow, Benedetto Vitiello, Gregory Clarke, Martin Keller, Graham J. Emslie, Neal Ryan, Giovanna Porta, Satish Iyengar, Louise Ritz, Jamie Zelanzny, Matthew Onorato, David Brent

Research output: Contribution to journalArticlepeer-review

11 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)5-10
Number of pages6
JournalJournal of Child and Adolescent Psychopharmacology
Issue number1
StatePublished - Feb 1 2012

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health
  • Pharmacology (medical)


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