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Cited by 1,735Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesPsychotherapy Techniques and Applications

Fluoxetine, Cognitive-Behavioral Therapy, and Their Combination for Adolescents With Depression: Treatment for Adolescents With Depression Study (TADS) Randomized Controlled Trial

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Treatment for Adolescents With Depression Study (TADS) Team·2004·JAMA
DOI 10.1001/jama.292.7.807
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Abstract

CONTEXT: Initial treatment of major depressive disorder in adolescents may include cognitive-behavioral therapy (CBT) or a selective serotonin reuptake inhibitor (SSRI). However, little is known about their relative or combined effectiveness. OBJECTIVE: To evaluate the effectiveness of 4 treatments among adolescents with major depressive disorder. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of a volunteer sample of 439 patients between the ages of 12 to 17 years with a primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of major depressive disorder. The trial was conducted at 13 US academic and community clinics between spring 2000 and summer 2003. INTERVENTIONS: Twelve weeks of (1) fluoxetine alone (10 to 40 mg/d), (2) CBT alone, (3) CBT with fluoxetine (10 to 40 mg/d), or (4) placebo (equivalent to 10 to 40 mg/d). Placebo and fluoxetine alone were administered double-blind; CBT alone and CBT with fluoxetine were administered unblinded. MAIN OUTCOME MEASURES: Children's Depression Rating Scale-Revised total score and, for responder analysis, a (dichotomized) Clinical Global Impressions improvement score. RESULTS: Compared with placebo, the combination of fluoxetine with CBT was statistically significant (P =.001) on the Children's Depression Rating Scale-Revised. Compared with fluoxetine alone (P =.02) and CBT alone (P =.01), treatment of fluoxetine with CBT was superior. Fluoxetine alone is a superior treatment to CBT alone (P =.01). Rates of response for fluoxetine with CBT were 71.0% (95% confidence interval [CI], 62%-80%); fluoxetine alone, 60.6% (95% CI, 51%-70%); CBT alone, 43.2% (95% CI, 34%-52%); and placebo, 34.8% (95% CI, 26%-44%). On the Clinical Global Impressions improvement responder analysis, the 2 fluoxetine-containing conditions were statistically superior to CBT and to placebo. Clinically significant suicidal thinking, which was present in 29% of the sample at baseline, improved significantly in all 4 treatment groups. Fluoxetine with CBT showed the greatest reduction (P =.02). Seven (1.6%) of 439 patients attempted suicide; there were no completed suicides. CONCLUSION: The combination of fluoxetine with CBT offered the most favorable tradeoff between benefit and risk for adolescents with major depressive disorder.

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  • There have been inconsistent findings regarding the combined use of SSRIs and CBT with adolescents.

    “Further, there have been inconsistent findings regarding the combined use of SSRIs and CBT with adolescents (Clarke 2005; Goodyer 2007; March 2004; Melvin 2006).”

    From Interventions for preventing relapse and recurrence of a depressive disorder in children and adolescents (2012) · cites this paper as March 2004

    The Treatment With CBT Combined With Fluoxetine section reports a favorable result for the combination in adolescents, so this paper supplies one relevant finding. It also says this was the first randomized trial of the combination in clinically depressed youth; it does not itself establish that findings across adolescent studies were inconsistent. Page numbers are unavailable in our copy. (LLM, conf=0.78)

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  • A recent multi-site controlled trial found that CBT was equivalent to pill-placebo for reduction of depressive symptoms in adolescents.

    “a recent multi-site controlled trial found that CBT was equivalent to pill-placebo for reduction of depressive symptoms in adolescents (Treatment for Adolescents With Depression Study (TADS) Team, US, 2004).”

    From The empirical status of cognitive-behavioral therapy: A review of meta-analyses (2006) · cites this paper as Treatment for Adolescents With Depression Study (TADS) Team, US, 2004

  • Evidence-based treatments for pediatric depression and anxiety include SSRI, SNRI medications and CBT, used separately or in combination.

    “Evidence-based treatments for pediatric depression and anxiety include selective serotonin and serotonin-norepinephrine reuptake inhibitor (SSRI, SNRI) medications and cognitive behavioral therapy (CBT), used separately or in combination [11-13].”

    From Chatbot-Delivered Cognitive Behavioral Therapy in Adolescents With Depression and Anxiety During the COVID-19 Pandemic: Feasibility and Acceptability Study (2022) · cites this paper as [11]

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Research works printed but not linked: 9

  1. Essau C, Dobson K. Epidemiology of depressive dis- orders. In: Essau C, Petermann F, eds. Depressive Dis- orders in Children and Adolescents: Epidemiology, Course and Treatment. Northvale, NJ: Jason Aron- son Inc; 1999:69-103.
  2. Emslie GJ, Heiligenstein JH, Wagner KD, et al. Fluoxetine for acute treatment of depression in chil- dren and adolescents: a placebo-controlled, random- ized clinical trial. J Am Acad Child Adolesc Psychia- try. 2002;41:1205-1215.
  3. Friedman MA, Detweiler JB, Leventhal HE, Horne R, Keitner G, Miller IW. Combined psychotherapy and pharmacotherapy for the treatment of major depres- sion. Clin Psychol Sci Prac. 2004;11:47-68.
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  6. Clarke G, Lewinshoh P, Hops H. Instructor's Manual for the Adolescent Coping With Depression Course. 4th ed. Eugene, Oregon: Castalia Press; 1990.
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Authors
Treatment for Adolescents With Depression Study (TADS) Team
Affiliations
Duke Medical Center (US)
Corresponding author
Treatment for Adolescents With Depression Study (TADS) Team
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2004-08-18
Volume
292
Issue
7
Pages
807
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.292.7.807
OpenAlex
W2254051562
Cited by
1,735
References
43
Citations by year
2026: 43 · 2025: 35 · 2024: 72 · 2023: 41 · 2022: 63 · 2021: 60 · 2020: 50 · 2019: 64 · 2018: 54 · 2017: 42 · 2016: 79 · 2015: 75 · 2014: 83 · 2013: 85 · 2012: 92
FWCI
81.91
Type
journal article
Language
en
Open access
Locations
  • JAMA (publishedVersion)
  • PubMed (publishedVersion)
  • Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
Funders
  • Yale University
  • Kaiser Permanente
  • University of Pittsburgh
  • Carnegie Mellon University
  • University of Texas at Austin
  • National Institutes of Health (98DS-0008)
  • National Institute of Mental Health
Topics
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
Keywords
fluoxetine, cognitive behavioral therapy, adolescent depression, major depressive disorder, selective serotonin reuptake inhibitors, combination therapy, treatment response, suicidal ideation, Children's Depression Rating Scale-Revised, clinical global impression, placebo response, medication adherence, relapse prevention, psychoeducation, psychotherapy dropout
MeSH terms
Adolescent, Combined Modality Therapy, Major Depressive Disorder, Depressive Disorder, Major, Female, Fluoxetine, Humans, Male, Psychiatric Status Rating Scales, Risk, Suicide, Cognitive Behavioral Therapy, Selective Serotonin Reuptake Inhibitors, Antidepressive Agents, Second-Generation

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