PAXIL - PROZAC - ZOLOFT  ADULT TRIALS
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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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Screening

PAXIL - PROZAC - ZOLOFT ADULT TRIALS

Occurrence of suicidality

screening

Run-in/wash out

randomization

drug

pbo

Start

treatment

Stop

treatment

follow-up


Screening

PAXIL – PROZAC - ZOLOFT ADULT TRIALS

Analysis of suicidality

screening

Run-in/wash out

randomization

drug

pbo

Start

treatment

Stop

treatment

follow - up




Screening

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 placebo wash out cases removed from placebo group
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 placebo wash out cases removed from pbo group
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.


Screening

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.