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.
RCT Entities:
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.
Authors: John March; Helena C Kraemer; Madhukar Trivedi; John Csernansky; John Davis; Terence A Ketter; Ira D Glick Journal: Neuropsychopharmacology Date: 2010-08-25 Impact factor: 7.853
Authors: Betsy D Kennard; Susan G Silva; Taryn L Mayes; Paul Rohde; Jennifer L Hughes; Benedetto Vitiello; Christopher J Kratochvil; John F Curry; Graham J Emslie; Mark A Reinecke; John S March Journal: Am J Psychiatry Date: 2009-01-15 Impact factor: 18.112
Authors: Mark Shapiro; Susan G Silva; Scott Compton; Allan Chrisman; Joseph DeVeaugh-Geiss; Alfiee Breland-Noble; Douglas Kondo; Jerry Kirchner; John S March Journal: Child Adolesc Psychiatry Ment Health Date: 2009-03-25 Impact factor: 3.033