The Treatment for Adolescents With Depression Study (TADS)

• DOI: 10.1001/archpsyc.64.10.1132
• Publication Date: 2007-10-01T16:12:43Z
• Authors: Bennett L. Leventhal; Bennett L. Leventhal; Randy LaGrone; Sarah Arszman; Norah C. Feeny; John S. March; Benedetto Vitiello; Taryn L. Mayes; Susan Baab; Steven McNulty; Diane May; Bruce Waslick; Arman Danielyan; John F. Curry; Nili R. Benazon; Michael Sweeney; Kelly Posner; Susan G. Silva; Jennifer Wells; Beth D. Kennard; James Rochon; Paul Rohde; Elizabeth Podnies...; Anne Marie Albano; Hyung Koo; Stephen Petrycki; John A. Fairbank; Randi Dublin; Golda S. Ginsburg; Elizabeth B. Weller; Christopher J. Kr...; Karyn Riedal; Glenn S. Hirsch; Stephenie Frank; Graham J. Emslie; Naushad Jessani; Rachel H. Jacobs; Rachel H. Jacobs; Sanjeev Pathak; Michael Butkus; Brigette Vaughan; James Grimm; David R. Rosenberg; Gregory M. Rogers; Gregory M. Rogers; Elizabeth Kastelic; Charles D. Casat; Ronald A. Weller; Barbara J. Burns; Carroll W. Hughes; Marisa Elena Domino; Jeanette Kolker; Sheridan Stull; Mark A. Reinecke; Mark A. Reinecke; Karen C. Wells; John T. Walkup; Joanne B. Severe; Robert L. Findling; Marla Bartoi; Anne D. Simons; Michele Robins
• Keywords: Male; Suicide Prevention; Time Factors; Adolescent; Adolescent; Clinical Protocols; Combined Modality Therapy; Depressive Disorder, Major; Diagnostic and Statistical Manual of Mental Disorders; Double-Blind Method; Female; Fluoxetine; Humans; Male; Placebos; Psychiatric Status Rating Scales; Serotonin Uptake Inhibitors; Severity of Illness Index; Suicide; Time Factors; Treatment Outcome; United States; Cognitive Therapy; Psychiatry and Mental Health; Severity of Illness Index; Placebos; 03 medical and health sciences; 0302 clinical medicine; Clinical Protocols; Double-Blind Method; Fluoxetine; Humans; Psychiatric Status Rating Scales; Depressive Disorder, Major; Cognitive Behavioral Therapy; Combined Modality Therapy; United States; 3. Good health; Diagnostic and Statistical Manual of Mental Disorders; Suicide; Treatment Outcome; Female; Selective Serotonin Reuptake Inhibitors

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.To report effectiveness outcomes across 36 weeks of randomized treatment.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.Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder.All treatments were administered per protocol.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.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%).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.