SPECIAL SECTION: TREATMENT FOR ADOLESCENTS WITH DEPRESSION STUDY-TADS
Predictors and Moderators of Acute Outcome in the Treatment for Adolescents With Depression Study (TADS)

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ABSTRACT

Objective

To identify predictors and moderators of response to acute treatments among depressed adolescents (N = 439) randomly assigned to fluoxetine, cognitive-behavioral therapy (CBT), both fluoxetine and CBT, or clinical management with pill placebo in the Treatment for Adolescents With Depression Study (TADS).

Method

Potential baseline predictors and moderators were identified by a literature review. The outcome measure was a week 12 predicted score derived from the Children's Depression Rating Scale-Revised (CDRS-R). For each candidate moderator or predictor, a general linear model was conducted to examine main and interactive effects of treatment and the candidate variable on the CDRS-R predicted scores.

Results

Adolescents who were younger, less chronically depressed, higher functioning, and less hopeless with less suicidal ideation, fewer melancholic features or comorbid diagnoses, and greater expectations for improvement were more likely to benefit acutely than their counterparts. Combined treatment, under no condition less effective than monotherapy, was more effective than fluoxetine for mild to moderate depression and for depression with high levels of cognitive distortion, but not for severe depression or depression with low levels of cognitive distortion. Adolescents from high-income families were as likely to benefit from CBT alone as from combined treatment.

Conclusions

Younger and less severely impaired adolescents are likely to respond better to acute treatment than older, more impaired, or multiply comorbid adolescents. Family income level, cognitive distortions, and severity of depression may help clinicians to choose among acute interventions, but combined treatment proved robust in the presence of moderators. J. Am. Acad. Child Adolesc. Psychiatry, 2006;45(12):1427-1439.

Section snippets

Participants

As described elsewhere (TADS, 2005), participants were 439 adolescents, recruited at 13 clinical sites, who met DSM-IV criteria (American Psychiatric Association, 1994) for MDD, with stable depressed mood and functional impairment. Their demographic and clinical characteristics are detailed in a previous publication (TADS, 2005) and summarized in the introductory article to this special section by March and colleagues (March et al., 2006). More than half had a diagnosis in addition to MDD; 96%

RESULTS

Results of these analyses are summarized in Table 2. Of the 21 candidate variables tested, nine were determined to be predictors of treatment outcome and three were moderators.

DISCUSSION

Younger, higher functioning, less chronically depressed adolescents with fewer melancholic features, less suicidal ideation, less hopelessness, and higher expectations for improvement from their subsequently assigned treatment were less depressed than their counterparts after acute TADS treatment. Moderators of outcome included family income, severity of depression, and cognitive distortions. Of 21 variables examined as potential moderators or predictors, 12 served one of these functions for

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    National Institute of Mental Health (NIMH) Program Staff participated in the design and implementation of the TADS, analysis of the data, and in authoring this article. Lilly, Inc. provided fluoxetine and matching placebo under an independent educational grant to Duke University but otherwise had no role in the design or implementation of the study, data analysis, or in authoring this manuscript. The authors are indebted to the TADS scientific advisors (Susan Essock, Ph.D., Mount Sinai School of Medicine; Barbara Geller, M.D., Washington University in St. Louis; Joel Greenhouse, Ph.D., Carnegie Mellon University; Robert Johnson, M.D., New Jersey Medical School; James Leckman, M.D., Yale University; Lydia Lewis, Depression and Bipolar Support Alliance; Sue Marcus, Ph.D., Mount Sinai School of Medicine; Kevin Stark, Ph.D., University of Texas at Austin) for their contributions to the design and methods of the study; to our cognitive-behavioral therapy consultants, David Brent, M.D., and Greg Clarke, Ph.D.; to the Columbia Suicidality Classification Group led by Kelly Posner, Ph.D., including Maria Oquendo, M.D., Madelyn Gould, Ph.D., M.P.H., and Barbara Stanley, Ph.D.; and to the members of the NIMH Data and Safety Monitoring Board for monitoring the progress of the study. The protocol and manuals used in this study can be found on the web at https://trialweb.dcri.duke.edu/tads/manuals.html. The opinions and assertions contained in this report are the private views of the authors and are not to be construed as official or as reflecting the views of the NIMH, the National Institutes of Health, or the Department of Health and Human Services.

    TADS is supported by contract RFP-NIH-NIMH 98-DS-0008 from NIMH to Duke University Medical Center (John March, principal investigator).

    Disclosure: Dr. March is on the speakers' bureau of Pfizer and Eli Lilly and receives research support from Eli Lilly, Pfizer, and Wyeth. Dr. Silva is a consultant for Pfizer. Dr. Weller is a consultant for and/or receives grants from Otsuka, AstraZeneca, Pharma, Shire, and Jazz Pharmaceuticals. Dr. Ginsburg received an unrestricted research grant from Pfizer. Dr. Kratochvil receives research support from Eli Lilly, Forest, and GlaxoSmithKline and is a consultant for and on the speakers' bureau of Eli Lilly. Dr. Pathak receives research support from Forest. The other authors have no financial relationships to disclose.

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