Impact of the 2004 food and drug administration pediatric suicidality warning on antidepressant and psychotherapy treatment for new-onset depression

Satish Valluri, Julie M. Zito, Daniel J. Safer, Ilene H. Zuckerman, C. Daniel Mullins, James J. Korelitz

Research output: Contribution to journalArticle

Abstract

Objective: To assess the national impact of the March 2004 Food and Drug Administration (FDA) antidepressant suicidality warning on the outpatient treatment of new-onset depression in youth. METHOD:: A repeated measures, longitudinal design in a cohort of youth diagnosed with new-onset depression was used to assess pre- and post-FDA warning effects. US commercial insurance enrollees in the i3 INNOVUS database from January 2003 through December 2006 were examined. The study population included youth 2- to 17-years old with a new-onset depression diagnosis from July 2003 through June 2006 (N = 40,309). The main independent variables were the warning period (post- vs. pre-FDA warning) and age group (children vs. adolescents). The main outcome measures were youth with antidepressant dispensings and psychotherapy visits measured in 30-day intervals across 36 months following a new-onset diagnosis of any depressive disorder (N = 40,309) and specifically major depressive disorder (MDD) (N = 11,532). Results: Compared to youth with a new-onset diagnosis of depression in the pre-FDA warning period, youth with new-onset diagnosis of depression during the postwarning period had (1) A significantly lower likelihood of antidepressant use: (odds ratio [OR] = 0.85 [0.81-0.89]); When youth with the diagnosis of depression were separated into those with MDD and those with less severe depression diagnoses, only the latter had a significant postwarning antidepressant decline. (2) A significant increase in the odds of a psychotherapy visit (children, OR = 1.31 [1.23-1.40]; adolescents OR = 1.19 [1.15-1.24]). Conclusions: The FDA suicidality warning was associated with an overall decrease in antidepressant treatment for youth with a clinician-reported diagnosis of depression, but not for those with MDD. Also, following the warning, psychotherapy without medication increased.

Original languageEnglish (US)
Pages (from-to)947-954
Number of pages8
JournalMedical Care
Volume48
Issue number11
DOIs
StatePublished - Nov 2010

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United States Food and Drug Administration
Psychotherapy
Antidepressive Agents
Depression
Pediatrics
Major Depressive Disorder
Therapeutics
Odds Ratio
Depressive Disorder
Insurance
Outpatients
Age Groups
Outcome Assessment (Health Care)
Databases

Keywords

  • antidepressants
  • FDA
  • FDA warning
  • mental health
  • pediatric depression
  • SSRI
  • suicidality

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

Impact of the 2004 food and drug administration pediatric suicidality warning on antidepressant and psychotherapy treatment for new-onset depression. / Valluri, Satish; Zito, Julie M.; Safer, Daniel J.; Zuckerman, Ilene H.; Mullins, C. Daniel; Korelitz, James J.

In: Medical Care, Vol. 48, No. 11, 11.2010, p. 947-954.

Research output: Contribution to journalArticle

Valluri, Satish ; Zito, Julie M. ; Safer, Daniel J. ; Zuckerman, Ilene H. ; Mullins, C. Daniel ; Korelitz, James J. / Impact of the 2004 food and drug administration pediatric suicidality warning on antidepressant and psychotherapy treatment for new-onset depression. In: Medical Care. 2010 ; Vol. 48, No. 11. pp. 947-954.
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AU - Mullins, C. Daniel

AU - Korelitz, James J.

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AB - Objective: To assess the national impact of the March 2004 Food and Drug Administration (FDA) antidepressant suicidality warning on the outpatient treatment of new-onset depression in youth. METHOD:: A repeated measures, longitudinal design in a cohort of youth diagnosed with new-onset depression was used to assess pre- and post-FDA warning effects. US commercial insurance enrollees in the i3 INNOVUS database from January 2003 through December 2006 were examined. The study population included youth 2- to 17-years old with a new-onset depression diagnosis from July 2003 through June 2006 (N = 40,309). The main independent variables were the warning period (post- vs. pre-FDA warning) and age group (children vs. adolescents). The main outcome measures were youth with antidepressant dispensings and psychotherapy visits measured in 30-day intervals across 36 months following a new-onset diagnosis of any depressive disorder (N = 40,309) and specifically major depressive disorder (MDD) (N = 11,532). Results: Compared to youth with a new-onset diagnosis of depression in the pre-FDA warning period, youth with new-onset diagnosis of depression during the postwarning period had (1) A significantly lower likelihood of antidepressant use: (odds ratio [OR] = 0.85 [0.81-0.89]); When youth with the diagnosis of depression were separated into those with MDD and those with less severe depression diagnoses, only the latter had a significant postwarning antidepressant decline. (2) A significant increase in the odds of a psychotherapy visit (children, OR = 1.31 [1.23-1.40]; adolescents OR = 1.19 [1.15-1.24]). Conclusions: The FDA suicidality warning was associated with an overall decrease in antidepressant treatment for youth with a clinician-reported diagnosis of depression, but not for those with MDD. Also, following the warning, psychotherapy without medication increased.

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