TY - JOUR
T1 - Treatment for Adolescents with Depression Study (TADS)
T2 - Rationale, design, and methods
AU - March, John
AU - Silva, Susan
AU - Petrycki, Stephen
AU - Curry, John
AU - Wells, Karen
AU - Fairbank, John
AU - Burns, Barbara
AU - Domino, Marisa
AU - Vitiello, Benedetto
AU - Severe, Joanne
AU - Casat, Charles
AU - Kolker, Jeanette
AU - Feeny, Norah
AU - Findling, Robert
AU - Stull, Sheridan
AU - Baab, Susan
AU - Waslick, Bruce
AU - Sweeney, Michael
AU - Kentgen, Lisa
AU - Kandel, Rachel
AU - Walkup, John
AU - Ginsburg, Golda
AU - Kastelik, Elizabeth
AU - Koo, Hyung
AU - Kratochvil, Christopher
AU - May, Diane
AU - LaGrone, Randy
AU - Harrington, Martin
AU - Albano, Anne Marie
AU - Hirsch, Glenn
AU - Knibbs, Tracey
AU - Capili, Emlyn
AU - Reinecke, Mark
AU - Leventhal, Bennett
AU - Nageotte, Catherine
AU - Rogers, Gregory
AU - Pathak, Sanjeev
AU - Sallee, Floyd
AU - Cottingham, Elizabeth
AU - Wells, Jennifer
AU - Rohde, Paul
AU - Simons, Anne
AU - Grimm, James
AU - Hadjiyannakis, Katholiki
AU - Weller, Elizabeth
AU - Robins, Michele
AU - Weller, Ronald
AU - Jessani, Naushad
AU - Emslie, Graham
AU - Kennard, Beth
AU - Hughes, Carroll
AU - Ruberu, Maryse
AU - Benazon, Nili
AU - Rosenberg, David
AU - Butkus, Michael
AU - Bartoi, Marla
AU - Clarke, Greg
AU - Brent, David
AU - Koch, Gary
N1 - Funding Information:
TADS is funded by the NIMH as a contract to the Coordinating Center at Duke University Medical Center, with collaborating Program staff at the NIMH, statistical and other consultants, and collaborating scientists at 12 study centers. Under the direction of the Principal Investigator, John March, M.D., M.P.H., the Statistical Principal Investigator, Susan Silva, Ph.D., and the TADS Project Leader, Steven Petrycki, R.N., the Duke Clinical Research Institute provides overall leadership for the scientific integrity of the study as well as project leadership, site management, data management, budget and contractual services, Web‐site management, and pharmacy and randomization services. Using carefully defined site identification and selection procedures, the Coordinating Center identified collaborating sites (listed in the boilerplate authorship acknowledgment) that collectively met the objectives of the RFP for geographic, ethnic, and practice diversity, each of which is essential to recruiting a representative sample of depressed adolescents. Oversight with respect to the TADS scientific agenda is provided by an eight‐member Scientific Advisory Board, chartered by the NIMH, which meets yearly and as needed to advise the NIMH on the scientific soundness of the trial and the performance of the Coordinating Center. Human subjects oversight is provided by the Duke Institutional Review Board (IRB) and site IRBs as well as by the NIMH Data Safety and Monitoring Board and by the NIH Office of Health and Research Protection.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2003/5
Y1 - 2003/5
N2 - 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.
AB - 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.
KW - Adolescence
KW - Cognitive-behavioral therapy
KW - Depression
KW - Medication
KW - Methods
KW - Randomized controlled trial
KW - Serotonin reuptake inhibitor
KW - Treatment
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U2 - 10.1097/01.CHI.0000046839.90931.0D
DO - 10.1097/01.CHI.0000046839.90931.0D
M3 - Article
C2 - 12707557
AN - SCOPUS:0042783158
SN - 0890-8567
VL - 42
SP - 531
EP - 542
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 5
ER -