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1.
 Andy Mosholder briefing document. Food and Drug Administration Psychopharmacologic Drugs Advisory Committee Web site.Available at:http://www.fda.gov/ohrms/dockets/ac/cder04.html#PsychopharmacologicDrugsAccessed March 20, 2005
2.
March  JSilva  SPetrycki  SCurry  JWells  KFairbank  JBurns  BDomino  MMcNulty  SVitiello  BSevere  JTreatment for Adolescents With Depression Study Team, Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial.  JAMA 2004;292807- 820PubMedGoogle ScholarCrossref
3.
Sterne  JACBrandburn  MJEgger  M Meta-analysis in STATA. In:Egger  MSmith  GDAltman  DGeds. Systematic Reviews in Health Care: Meta-analysis in Context London, England BMJ Publishing Group2001;347- 369Google Scholar
4.
Sutton  AJAbrams  KR Methods for Meta-analysis in Medical Research.  New York, NY John Wiley & Sons Inc2002;69
5.
Deeks  JJAltman  DGBrandburn  MJ Statistical methods for examining heterogeneity and combining results from several studies in meta-analysis. In:Egger  MSmith  GDAltman  DGeds. Systematic Reviews in Health Care: Meta-analysis in Context London, England BMJ Publishing Group2001;297Google Scholar
6.
Mayer-Gross  WSlater  ERoth  M Clinical Psychiatry.  London, England Bailliere, Tindall, and Cassell1960;231
7.
Teicher  MHGlod  CCole  JO Emergence of intense suicidal preoccupation during fluoxetine treatment.  Am J Psychiatry 1990;147207- 210PubMedGoogle Scholar
8.
Beasley  CM  JrDornseif  BEBosomworth  JCSayler  MERampey  AH  JrHeiligenstein  JHThompson  VLMurphy  DJMasica  DN Fluoxetine and suicide: a meta-analysis of controlled trials of treatment for depression.  BMJ 1991;303685- 692PubMedGoogle ScholarCrossref
9.
Khan  AWarner  HABrown  WA Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials.  Arch Gen Psychiatry 2000;57311- 317PubMedGoogle ScholarCrossref
10.
Storosum  JGvan Zweiten  BJvan den Brink  WGersons  BPRBroekmans  AW Suicide risk in placebo-controlled studies of major depression.  Am J Psychiatry 2001;1581271- 1275PubMedGoogle ScholarCrossref
11.
Hammad  TMosholder  ABoehm  GRacoosin  JALaughren  T Incidence of suicide in randomized controlled trials of patients with major depressive disorder [abstract].  Pharmacoepidemiol Drug Saf 2003;12S156Google Scholar
12.
King  RARiddle  MAChappell  PBHardin  MTAnderson  GMLombroso  P Emergence of self-destructive phenomena in children and adolescents during fluoxetine treatment.  J Am Acad Child Adolesc Psychiatry 1991;30179- 186PubMedGoogle ScholarCrossref
13.
National Center for Injury Prevention and Control, Office of Statistics and Programming, WISQARS fatal injuries: mortality reports. Available at:http://webapp.cdc.gov/sasweb/ncipc/mortrate.htmlAccessed April 19, 2005
14.
Olfson  MShaffer  DMarcus  SCGreenberg  T Relationship between antidepressant medication treatment and suicide in adolescents.  Arch Gen Psychiatry 2003;60978- 982PubMedGoogle ScholarCrossref
15.
Gray  DBMoskos  MKeller  T Suicide 2003: Proceedings of the 36th Annual Conference of the American Association of Suicidology, Santa Fe, NM; April 21-26, 2003.  Washington, DC American Association of Suicidology2004;
16.
Leon  ACMarzuk  PMTardiff  KTeres  JJ Paroxetine, other antidepressants, and youth suicide in New York City: 1993 through 1998.  J Clin Psychiatry 2004;65915- 918PubMedGoogle ScholarCrossref
17.
Tarek A. Hammad briefing document. Food and Drug Administration Psychopharmacologic Drugs Advisory Committee Web site Available at:http://www.fda.gov/ohrms/dockets/ac/cder04.html#PsychopharmacologicDrugsAccessed March 20, 2005
18.
Brent  DA Antidepressants and pediatric depression: the risk of doing nothing.  N Engl J Med 2004;3511598- 1601PubMedGoogle ScholarCrossref
19.
Newman  TB A black-box warning for antidepressants in children?  N Engl J Med 2004;3511595- 1598PubMedGoogle ScholarCrossref
Original Article
March 2006

Suicidality in Pediatric Patients Treated With Antidepressant Drugs

Author Affiliations

Author Affiliations: Division of Neuropharmacological Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md.

Arch Gen Psychiatry. 2006;63(3):332-339. doi:10.1001/archpsyc.63.3.332
Abstract

Context  There has been concern that widely used antidepressant agents might be associated with an increased risk of suicidal ideation and behavior (suicidality) in pediatric patients.

Objective  To investigate the relationship between antidepressant drugs and suicidality in pediatric patients participating in randomized, placebo-controlled trials.

Data Sources  Data were derived from 23 trials conducted in 9 drug company–supported programs evaluating the effectiveness of antidepressants in pediatric patients and 1 multicenter trial (the Treatment for Adolescents With Depression Study) that evaluated fluoxetine hydrochloride.

Study Selection  All placebo-controlled trials submitted to the Food and Drug Administration were eligible for inclusion. Evaluable data were derived from 4582 patients in 24 trials. Sixteen trials studied patients with major depressive disorder, and the remaining 8 studied obsessive-compulsive disorder (n = 4), generalized anxiety disorder (n = 2), attention-deficit/hyperactivity disorder (n = 1), and social anxiety disorder (n = 1). Only 20 trials were included in the risk ratio analysis of suicidality because 4 trials had no events in the drug or placebo groups.

Data Extraction  Individual patient data were available for all the trials.

Data Synthesis  A meta-analysis was conducted to obtain overall suicidality risk estimates for each drug individually, for selective serotonin reuptake inhibitors in depression trials as a group, and for all evaluable trials combined. There were no completed suicides in any of these trials. The multicenter trial was the only individual trial to show a statistically significant risk ratio (4.62; 95% confidence interval [CI], 1.02-20.92). The overall risk ratio for selective serotonin reuptake inhibitors in depression trials was 1.66 (95% CI, 1.02-2.68) and for all drugs across all indications was 1.95 (95% CI, 1.28-2.98). The overall risk difference for all drugs across all indications was 0.02 (95% CI, 0.01-0.03).

Conclusion  Use of antidepressant drugs in pediatric patients is associated with a modestly increased risk of suicidality.

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