title: Out of the black box: treatment of resistant depression in adolescents and the antidepressant controversy.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.affiliation: Division of Child and Adolescent Psychiatry, The University of Texas Medical Branch, Galveston, Texas 77555, USA. kwagner@utmb.edu
authors.forename: Karen Dineen
authors.initials: KD
authors.lastname: Wagner
authors.forename: Joan Rosenbaum
authors.initials: JR
authors.lastname: Asarnow
authors.forename: Benedetto
authors.initials: B
authors.lastname: Vitiello
authors.forename: Gregory
authors.initials: G
authors.lastname: Clarke
authors.forename: Martin
authors.initials: M
authors.lastname: Keller
authors.forename: Graham J
authors.initials: GJ
authors.lastname: Emslie
authors.forename: Neal
authors.initials: N
authors.lastname: Ryan
authors.forename: Giovanna
authors.initials: G
authors.lastname: Porta
authors.forename: Satish
authors.initials: S
authors.lastname: Iyengar
authors.forename: Louise
authors.initials: L
authors.lastname: Ritz
authors.forename: Jamie
authors.initials: J
authors.lastname: Zelanzny
authors.forename: Matthew
authors.initials: M
authors.lastname: Onorato
authors.forename: David
authors.initials: D
authors.lastname: Brent
mesh_terms: D000293:Adolescent; D002648:Child; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D003511:Cyclohexanols / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000628:therapy*; D004348:Drug Labeling; D004351:Drug Resistance; D006801:Humans; D018579:Patient Selection; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000069470:Venlafaxine Hydrochloride; D000092864:Suicide Prevention
chemical_list: D003511:Cyclohexanols; D017367:Selective Serotonin Reuptake Inhibitors; D000069470:Venlafaxine Hydrochloride