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Treatment for Adolescents with Depression Study (TADS): safety results.

Publication ,  Journal Article
Emslie, G; Kratochvil, C; Vitiello, B; Silva, S; Mayes, T; McNulty, S; Weller, E; Waslick, B; Casat, C; Walkup, J; Pathak, S; Rohde, P ...
Published in: Journal of the American Academy of Child and Adolescent Psychiatry
December 2006

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).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.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.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.

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Published In

Journal of the American Academy of Child and Adolescent Psychiatry

DOI

EISSN

1527-5418

ISSN

0890-8567

Publication Date

December 2006

Volume

45

Issue

12

Start / End Page

1440 / 1455

Related Subject Headings

  • Surveys and Questionnaires
  • Suicide, Attempted
  • Male
  • Life Change Events
  • Humans
  • Fluoxetine
  • Female
  • Double-Blind Method
  • Diagnostic and Statistical Manual of Mental Disorders
  • Developmental & Child Psychology
 

Citation

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Emslie, G., Kratochvil, C., Vitiello, B., Silva, S., Mayes, T., McNulty, S., … TADS Team, . (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
Emslie, Graham, Christopher Kratochvil, Benedetto Vitiello, Susan Silva, Taryn Mayes, Steven McNulty, Elizabeth Weller, et al. “Treatment for Adolescents with Depression Study (TADS): safety results.Journal of the American Academy of Child and Adolescent Psychiatry 45, no. 12 (December 2006): 1440–55. https://doi.org/10.1097/01.chi.0000240840.63737.1d.
Emslie G, Kratochvil C, Vitiello B, Silva S, Mayes T, McNulty S, et al. Treatment for Adolescents with Depression Study (TADS): safety results. Journal of the American Academy of Child and Adolescent Psychiatry. 2006 Dec;45(12):1440–55.
Emslie, Graham, et al. “Treatment for Adolescents with Depression Study (TADS): safety results.Journal of the American Academy of Child and Adolescent Psychiatry, vol. 45, no. 12, Dec. 2006, pp. 1440–55. Epmc, doi:10.1097/01.chi.0000240840.63737.1d.
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, Columbia Suicidality Classification Group, TADS Team. Treatment for Adolescents with Depression Study (TADS): safety results. Journal of the American Academy of Child and Adolescent Psychiatry. 2006 Dec;45(12):1440–1455.
Journal cover image

Published In

Journal of the American Academy of Child and Adolescent Psychiatry

DOI

EISSN

1527-5418

ISSN

0890-8567

Publication Date

December 2006

Volume

45

Issue

12

Start / End Page

1440 / 1455

Related Subject Headings

  • Surveys and Questionnaires
  • Suicide, Attempted
  • Male
  • Life Change Events
  • Humans
  • Fluoxetine
  • Female
  • Double-Blind Method
  • Diagnostic and Statistical Manual of Mental Disorders
  • Developmental & Child Psychology