Treatment for Adolescents with Depression Study (TADS): Rationale, design, and methods

John March, Susan Silva, Stephen Petrycki, John Curry, Karen Wells, John Fairbank, Barbara Burns, Marisa Domino, Benedetto Vitiello, Joanne Severe, Charles Casat, Jeanette Kolker, Norah Feeny, Robert Findling, Sheridan Stull, Susan Baab, Bruce Waslick, Michael Sweeney, Lisa Kentgen, Rachel KandelJohn Walkup, Golda Ginsburg, Elizabeth Kastelik, Hyung Koo, Christopher Kratochvil, Diane May, Randy LaGrone, Martin Harrington, Anne Marie Albano, Glenn Hirsch, Tracey Knibbs, Emlyn Capili, Mark Reinecke, Bennett Leventhal, Catherine Nageotte, Gregory Rogers, Sanjeev Pathak, Floyd Sallee, Elizabeth Cottingham, Jennifer Wells, Paul Rohde, Anne Simons, James Grimm, Katholiki Hadjiyannakis, Elizabeth Weller, Michele Robins, Ronald Weller, Naushad Jessani, Graham Emslie, Beth Kennard, Carroll Hughes, Maryse Ruberu, Nili Benazon, David Rosenberg, Michael Butkus, Marla Bartoi, Greg Clarke, David Brent, Gary Koch

Research output: Contribution to journalArticle

138 Scopus citations

Abstract

Objectives: A rapidly growing empirical literature on the treatment of major depressive disorder (MDD) in youth supports the efficacy of short-term treatment with depression-specific cognitive-behavioral therapy or medication management with a selective serotonin reuptake inhibitor. These studies also identify a substantial probability of partial response and of relapse, which might be addressed by more intensive, longer-term treatments. Method: Funded by the National Institute of Mental Health, the Treatment for Adolescents With Depression Study (TADS) is a multicenter, randomized, masked effectiveness trial designed to evaluate the short-term (12-week) and long-term (36-week) effectiveness of four treatments for adolescents with MDD: fluoxetine, cognitive-behavioral therapy, their combination, and, acutely, pill placebo. A volunteer sample of 432 subjects aged 12-17 years (inclusive) with a primary DSM-IV diagnosis of MDD who are broadly representative of patients seen in clinical practice will enter the study. The primary dependent measures rated blindly by an independent evaluator are the Children's Depression Rating Scale and, for responder analysis, a dichotomized Clinical Global Impressions- Improvement score. Consistent with an intent-to-treat analysis, all patients, regardless of treatment status, return for all scheduled assessments. Results: This report describes the design of the trial, the rationale for the design choices made, and the methods used to carry out the trial. Conclusion: When completed, TADS will improve our understanding of how best to initiate treatment for adolescents with MDD.

Original languageEnglish (US)
Pages (from-to)531-542
Number of pages12
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume42
Issue number5
DOIs
Publication statusPublished - May 2003

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Keywords

  • Adolescence
  • Cognitive-behavioral therapy
  • Depression
  • Medication
  • Methods
  • Randomized controlled trial
  • Serotonin reuptake inhibitor
  • Treatment

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology

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