Treatment for Adolescents with Depression Study (TADS): Safety results

Graham Emslie, Christopher Kratochvil, Benedetto Vitiello, Susan Silva, Taryn Mayes, Steven McNulty, Elizabeth Weller, Bruce Waslick, Charles Casat, John Walkup, Sanjeev Pathak, Paul Rohde, Kelly Posner, John March, Maria Oquendo, Madelyn Gould, Barbara Stanley

Research output: Contribution to journalArticle

123 Scopus citations

Abstract

OBJECTIVE: To compare the rates of physical, psychiatric, and suicide-related events in adolescents with MDD treated with fluoxetine alone (FLX), cognitive-behavioral therapy (CBT), combination treatment (COMB), or placebo (PBO). METHOD: Safety assessments included adverse events (AEs) collected by spontaneous report, as well as systematic measures for specific physical and psychiatric symptoms. Suicidal ideation and suicidal behavior were systematically assessed by self- and clinician reports. Suicidal events were also reanalyzed by the Columbia Group and expert raters using the Columbia-Classification Algorithm for Suicidal Assessment used in the U.S. Food and Drug Administration reclassification effort. RESULTS: Depressed adolescents reported high rates of physical symptoms at baseline, which improved as depression improved. Sedation, insomnia, vomiting, and upper abdominal pain occurred in at least 2% of those treated with FLX and/or COMB and at twice the rate of placebo. The rate of psychiatric AEs was 11% in FLX, 5.6% in COMB, 4.5% in PBO, and 0.9% in CBT. Suicidal ideation improved overall, with greatest improvement in COMB. Twenty-four suicide-related events occurred during the 12-week period: 5 patients (4.7%) in COMB, 10 (9.2%) in FLX, 5 (4.5%) in CBT, and 3 (2.7%) in placebo. Statistically, only FLX had more suicide-related events than PBO (p =.0402, odds ratio (OR) = 3.7, 95% CI 1.00-63.7). Only five actual attempts occurred (2 COMB, 2 FLX, 1 CBT, 0 PBO). There were no suicide completions. CONCLUSIONS: Different methods for eliciting AEs produce different results. In general, as depression improves, physical complaints and suicidal ideation decrease in proportion to treatment benefit. In this study, psychiatric AEs and suicide-related events are more common in FLX-treated patients. COMB treatment may offer a more favorable safety profile than medication alone in adolescent depression. Copyright 2006

Original languageEnglish (US)
Pages (from-to)1440-1455
Number of pages16
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume45
Issue number12
DOIs
StatePublished - Dec 1 2006

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Keywords

  • Adverse events
  • Cognitive-behavioral therapy
  • Fluoxetine
  • Major depressive disorder

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

Cite this

Emslie, G., Kratochvil, C., Vitiello, B., Silva, S., Mayes, T., McNulty, S., Weller, E., Waslick, B., Casat, C., Walkup, J., Pathak, S., Rohde, P., Posner, K., March, J., Oquendo, M., Gould, M., & Stanley, B. (2006). Treatment for Adolescents with Depression Study (TADS): Safety results. Journal of the American Academy of Child and Adolescent Psychiatry, 45(12), 1440-1455. https://doi.org/10.1097/01.chi.0000240840.63737.1d