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PAXIL - PROZAC - ZOLOFT ADULT TRIALS Occurrence of suicidality. screening. Run-in/wash out. randomization. drug. pbo. Start treatment. Stop treatment. follow-up. PAXIL – PROZAC - ZOLOFT ADULT TRIALS Analysis of suicidality. screening. Run-in/wash out. randomization. drug. pbo.
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PAXIL - PROZAC - ZOLOFT ADULT TRIALS Occurrence of suicidality screening Run-in/wash out randomization drug pbo Start treatment Stop treatment follow-up
PAXIL – PROZAC - ZOLOFT ADULT TRIALS Analysis of suicidality screening Run-in/wash out randomization drug pbo Start treatment Stop treatment follow - up
Suicides Attempts RR 95% CI 8 8 8 8 8 8 8 0.01 0.1 1 10 100 prevent cause Antidepressant effect Healy D, Whitaker C. J Psychiatry Neurosci 2003;28:331-7.
Adult Suicides: SSRI v PlaceboWash-out cases removed from placebo group RR=2.6 Healy D. J Psychiatry Neurosci 2003;28(5)331-7.
Adult Suicide attempts: SSRI v. PlaceboWash-out cases removed from pbo group RR=2.7 Healy D. J Psychiatry Neurosci 2003;28(5)331-7.
Pediatric Suicide-Related Events in DepressionSSRI v. Placebo RR=1.7 Loughren T. Team Leader, Psychiatric Drugs Products Group, FDA. Presented at FDA Adv Comm Mtg, Feb 2, 2004.