A Ten-Week Study Evaluating The Effectiveness And Safety Of Zoloft In Children And Adolescents With A Diagnosis Of PTSD

Phase 3 Terminated 160 enrolled Viatris Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the safety and efficacy of sertraline compared to placebo in children and adolescents (6 to 17 years of age) who are outpatients with Posttraumatic Stress Disorder.

Timeline

Start: 2002-11
Primary completion: —
Completion: 2007-07

Outcome

Missed primary endpoint

Stopped: “Please see Detailed Description below for termination reason.”

paper There was no difference between sertraline and placebo in least squares (LS) mean change in the UCLA PTSD-I score PMID 21186964 ↗

paper did not demonstrate efficacy when compared to placebo during 10 weeks of treatment. PMID 21186964 ↗

Publications

Robb AS, Cueva JE, Sporn J, Yang R, Vanderburg DG. Sertraline treatment of children and adolescents with posttraumatic stress disorder: a double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2010 Dec;20(6):463-71. doi: 10.1089/cap.2009.0115.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sertraline	Small molecule	50 mg	—
Subject	Sertraline	Small molecule	200 mg	—