drugset / Trial / NCT01130103

Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack

NCT01130103 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.

Timeline

Start
2004-03
Primary completion
2010-02
Completion
2010-02

Outcome

Met primary endpoint

registry analysis (superiority or other test); Paroxetine vs Placebo Pill; p = .01; incident rate ratio 0.50 (95% CI .30 to .85); Mixed Models Analysis NCT01130103 ↗

registry analysis (superiority or other test); Paroxetine vs Placebo Pill; p = .03; Odds Ratio (OR) 12.6 (95% CI 1.23 to 129); Mixed Models Analysis NCT01130103 ↗

paper Patients treated with prolonged exposure plus paroxetine experienced significantly greater improvement in PTSD symptoms (incidence rate ratio=0.50, 95% CI=0.30-0.85) PMID 21908494 ↗

paper remission status (odds ratio=12.6, 95% CI=1.23-129) during 10 weeks of combined treatment than patients treated with prolonged exposure plus placebo. PMID 21908494 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Paroxetine Small molecule 12.5 mg —
Subject Paroxetine Small molecule 50 mg —