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Thinking Outside the (Black) Box: Antidepressants, Suicidality, and Research Synthesis.

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Bibliographic Details
Title:	Thinking Outside the (Black) Box: Antidepressants, Suicidality, and Research Synthesis.
Authors:	Greenhouse, Joel B., Kelleher, Kelly J.
Source:	Pediatrics. Jul2005, Vol. 116 Issue 1, p231-233. 3p.
Subjects:	Antidepressants, Suicidal behavior of children, Teenage suicide, Suicide risk factors, Primary care, Psychiatric drugs, United States. Food & Drug Administration
Geographic Terms:	United States
Abstract:	This article discusses issues on the association of antidepressants with suicidality among children and teenagers. In this issue of Pediatrics, L. Leslie and colleagues review the evidence, deliberations and recommendations of the U.S. Food and Drug Administration scientific advisory committees that led to the black-box warning on the use of antidepressants for children and adolescents. Their article raises a number of critical questions about how we got to this point, including questions about federal drug-regulatory processes and the motivation of pharmaceutical companies to design, implement and report scientifically rigorous trials. Although the increased risk of suicidal behavior and ideation for children and adolescents who use antidepressants is statistically significant. In this article, the authors suggested several areas in which new research is necessary to advance the understanding of the safe and effective use of antidepressants in children and adolescents. First, there is a need to identify subgroups of children based on pretreatment risk factors for suicidality, for whom the use of antidepressants might be contraindicated. Second, there is a need to identify mechanisms of action that explain the relationship between antidepressant use and the increased risk of suicidal behavior and ideation in children. Finally, even without knowledge of the mechanisms by which risk is increased, there is a need to identify ways to implement close monitoring and careful dose titration of patients, especially in primary care settings to avoid adverse effects and relieve symptoms. In general, not nearly enough research has been done on the delivery of treatments and services for young persons on psychiatric drugs.
Database:	Psychology and Behavioral Sciences Collection

Description
Abstract:	This article discusses issues on the association of antidepressants with suicidality among children and teenagers. In this issue of Pediatrics, L. Leslie and colleagues review the evidence, deliberations and recommendations of the U.S. Food and Drug Administration scientific advisory committees that led to the black-box warning on the use of antidepressants for children and adolescents. Their article raises a number of critical questions about how we got to this point, including questions about federal drug-regulatory processes and the motivation of pharmaceutical companies to design, implement and report scientifically rigorous trials. Although the increased risk of suicidal behavior and ideation for children and adolescents who use antidepressants is statistically significant. In this article, the authors suggested several areas in which new research is necessary to advance the understanding of the safe and effective use of antidepressants in children and adolescents. First, there is a need to identify subgroups of children based on pretreatment risk factors for suicidality, for whom the use of antidepressants might be contraindicated. Second, there is a need to identify mechanisms of action that explain the relationship between antidepressant use and the increased risk of suicidal behavior and ideation in children. Finally, even without knowledge of the mechanisms by which risk is increased, there is a need to identify ways to implement close monitoring and careful dose titration of patients, especially in primary care settings to avoid adverse effects and relieve symptoms. In general, not nearly enough research has been done on the delivery of treatments and services for young persons on psychiatric drugs.
ISSN:	00314005
DOI:	10.1542/peds.2005-1041