screening

1
PAXIL - PROZAC - ZOLOFT ADULT TRIALS Occurrence
of suicidality
screening
Run-in/wash out
randomization
drug
pbo
Start treatment
Stop treatment
follow-up
2
PAXIL PROZAC - ZOLOFT ADULT TRIALS Analysis of
suicidality
screening
Run-in/wash out
randomization
drug
pbo
Start treatment
Stop treatment
follow - up
3
PAXIL/SEROXAT 1989
DRUG Patients Suicides Suicidal Acts Suicides Suicidal Acts
Paroxetine Comparator Placebo Washout/ Run-In F-Up 2,963 1151 554 7 3 0 2 42 12 1 2 1.65 1.30 0.18
4
PAXIL/SEROXAT 1990/1
DRUG Patients Suicides Suicidal Acts Suicides Suicidal Acts
Paroxetine Comparator Placebo 2,963 1151 554 5 3 2 40 12 6 1.52 1.30 1.44
5
Healy D, Whitaker C. J Psychiatry Neurosci
200328331-7.
6
Adult Suicides SSRI v Placebo Wash-out cases
removed from placebo group
RR2.6
Healy D. J Psychiatry Neurosci 200328(5)331-7.
7
Adult Suicide attempts SSRI v. Placebo Wash-out
cases removed from pbo group
RR2.7
Healy D. J Psychiatry Neurosci 200328(5)331-7.
8
Pediatric Suicide-Related Events in
DepressionSSRI v. Placebo
RR1.7
Loughren T. Team Leader, Psychiatric Drugs
Products Group, FDA. Presented at FDA Adv Comm
Mtg, Feb 2, 2004.
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