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The Treatment for Adolescents With Depression Study (TADS)Long-term Effectiveness and Safety Outcomes
The TADS Team
Arch Gen Psychiatry. 2007;64(10):1132-1143.
Context The Treatment for Adolescents With Depression Study evaluates the effectiveness of fluoxetine hydrochloride therapy, cognitive behavior therapy (CBT), and their combination in adolescents with major depressive disorder.
Objective To report effectiveness outcomes across 36 weeks of randomized treatment.
Design and Setting Randomized, controlled trial conducted in 13 academic and community sites in the United States. Cognitive behavior and combination therapies were not masked, whereas administration of placebo and fluoxetine was double-blind through 12 weeks, after which treatments were unblinded. Patients assigned to placebo were treated openly after week 12, and the placebo group is not included in these analyses by design.
Participants Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder.
Interventions All treatments were administered per protocol.
Main Outcome Measures The primary dependent measures rated blind to treatment status by an independent evaluator were the Children's Depression Rating Scale–Revised total score and the response rate, defined as a Clinical Global Impressions–Improvement score of much or very much improved.
Results Intention-to-treat analyses on the Children's Depression Rating Scale–Revised identified a significant time x treatment interaction (P < .001). Rates of response were 73% for combination therapy, 62% for fluoxetine therapy, and 48% for CBT at week 12; 85% for combination therapy, 69% for fluoxetine therapy, and 65% for CBT at week 18; and 86% for combination therapy, 81% for fluoxetine therapy, and 81% for CBT at week 36. Suicidal ideation decreased with treatment, but less so with fluoxetine therapy than with combination therapy or CBT. Suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT (6.3%).
Conclusions In adolescents with moderate to severe depression, treatment with fluoxetine alone or in combination with CBT accelerates the response. Adding CBT to medication enhances the safety of medication. Taking benefits and harms into account, combined treatment appears superior to either monotherapy as a treatment for major depression in adolescents.
Trial Registration clinicaltrials.gov Identifier: NCT00006286
Author Affiliations: The TADS Team Authors: The TADS is coordinated by the Department of Psychiatry and Behavioral Sciences and the Duke Clinical Research Institute at Duke University Medical Center, Durham, North Carolina, in collaboration with the NIMH. The Coordinating Center principal collaborators are John S. March, Susan Silva, Stephen Petrycki, John Curry, Karen Wells, John Fairbank, Barbara Burns, Marisa Domino, and Steven McNulty. The NIMH principal collaborators are Benedetto Vitiello and Joanne Severe. Principal investigators and coinvestigators from the clinical sites are as follows: Charles Casat, Jeanette Kolker, and Karyn Riedal (Carolinas Medical Center, Charlotte, North Carolina); Norah Feeny, Robert Findling, Sheridan Stull, and Susan Baab (Case Western Reserve University, Cleveland, Ohio); Elizabeth B. Weller, Michele Robins, Ronald A. Weller, and Naushad Jessani (The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania); Bruce Waslick (Baystate Health/Tufts University, Springfield, Massachusetts), Michael Sweeney, and Randi Dublin (Columbia University, New York, New York); John Walkup, Golda Ginsburg, Elizabeth Kastelic, and Hyung Koo (The Johns Hopkins University, Baltimore, Maryland); Christopher Kratochvil, Diane May, Randy LaGrone, and Brigette Vaughan (University of Nebraska, Omaha); Anne Marie Albano (Columbia University), Glenn S. Hirsch and Elizabeth Podniesinki (New York University, New York); Mark Reinecke, Bennett Leventhal, Gregory Rogers, and Rachel Jacobs (University of Chicago, Chicago, Illinois, and Northwestern University, Evanston, Illinois); Sanjeev Pathak, Jennifer Wells, Sarah Arszman, and Arman Danielyan (Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio); Paul Rohde, Anne Simons, James Grimm, and Stephenie Frank (University of Oregon, Eugene); Graham Emslie, Beth Kennard, Carroll Hughes, and Taryn L. Mayes (The University of Texas Southwestern Medical Center, Dallas); David Rosenberg, Nili Benazon, Michael Butkus, and Marla Bartoi (Wayne State University, Detroit, Michigan); and Kelly Posner, for the Columbia University Suicidality Classification Group. James Rochon (Duke Clinical Research Institute, Durham) is statistical consultant.
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