PMID- 16553530
OWN - NLM
STAT- MEDLINE
DCOM- 20060818
LR  - 20131121
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 16
IP  - 1-2
DP  - 2006 Feb-Apr
TI  - Evaluation of suicidal thoughts and behaviors in children and adolescents taking 
      paroxetine.
PG  - 77-90
AB  - OBJECTIVE: The aim of this study was to summarize results of a blinded review of 
      potential suicidal events and analyses comparing incidence rates between 
      paroxetine- and placebo-treated pediatric patients. METHOD: One thousand one 
      hundred ninety-one (1191) children and adolescents received paroxetine (n = 642) 
      or placebo (n = 549) during placebo-controlled portions of all acute double-blind 
      trials of paroxetine (n = 5). An expert panel blindly reviewed and categorized 
      all identified cases detected by electronic and manual search of adverse events 
      (AEs), serious AEs, and selected cases as suicidal or non-suicidal behavior. 
      Incidence rates were calculated for suicide-related events and for rating scale 
      items assessing suicidality. RESULTS: Suicide-related events occurred more often 
      in paroxetine (22 of 642, 3.4%) than placebo groups (5 of 549, 0.9%); odds ratio 
      (OR) 3.86 (95% CI 1.45, 10.26; p = 0.003). All suicide-related events occurred in 
      adolescents of at least 12 years, except for 1 of 156 paroxetine-treated 
      children. All suicide attempts occurred in major depressive disorder (MDD); few 
      suicide-related events occurred in patients with a primary anxiety disorder. 
      Suicide item analyses did not reveal significant differences between paroxetine 
      and placebo. CONCLUSIONS: Adolescents treated with paroxetine showed an increased 
      risk of suicide-related events. Suicidality rating scales did not show this risk 
      difference. The presence of uncontrolled suicide risk factors, the relatively low 
      incidence of these events, and their predominance in adolescents with MDD make it 
      difficult to identify a single cause for suicidality in these pediatric patients.
FAU - Apter, Alan
AU  - Apter A
AD  - Schneiders Childrens Medical Center of Israel, Sackler School of Medicine, Petah 
      Tikva, Israel. eapter@clalit.org.il
FAU - Lipschitz, Alan
AU  - Lipschitz A
FAU - Fong, Regan
AU  - Fong R
FAU - Carpenter, David J
AU  - Carpenter DJ
FAU - Krulewicz, Stan
AU  - Krulewicz S
FAU - Davies, John T
AU  - Davies JT
FAU - Wilkinson, Christel
AU  - Wilkinson C
FAU - Perera, Philip
AU  - Perera P
FAU - Metz, Alan
AU  - Metz A
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 41VRH5220H (Paroxetine)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Humans
MH  - Mental Disorders/drug therapy/*epidemiology/psychology
MH  - Paroxetine/*adverse effects
MH  - *Randomized Controlled Trials as Topic
MH  - Risk Factors
MH  - *Suicide/psychology
MH  - *Suicide, Attempted/psychology
RF  - 26
EDAT- 2006/03/24 09:00
MHDA- 2006/08/19 09:00
CRDT- 2006/03/24 09:00
PHST- 2006/03/24 09:00 [pubmed]
PHST- 2006/08/19 09:00 [medline]
PHST- 2006/03/24 09:00 [entrez]
AID - 10.1089/cap.2006.16.77 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2006 Feb-Apr;16(1-2):77-90. doi: 
      10.1089/cap.2006.16.77.