Out of the Black Box: Treatment of Resistant Depression in Adolescents and the Antidepressant Controversy
- 1 February 2012
- journal article
- research article
- Published by Mary Ann Liebert Inc in Journal of Child and Adolescent Psychopharmacology
- Vol. 22 (1), 5-10
- https://doi.org/10.1089/cap.2011.0045
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. 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.This publication has 22 references indexed in Scilit:
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