A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD)

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country160 target enrollmentNovember 2002

ConditionsStress Disorders, Post-Traumatic

DrugsZoloft (Sertraline)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Stress Disorders, Post-Traumatic
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 160
Locations: 1
Primary Endpoint: The primary efficacy parameter is the University of California at Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I).
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

This study was terminated on July 11, 2007. The results of the primary endpoint analysis at the interim showed that the Zoloft group was not significantly different than the placebo on the primary endpoint and therefore the decision was made to terminate the trial. The decision to terminate the trial was not based on any safety concerns.

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

July 2007

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must be from 6 to 17 years of age and will have a maximum age of 17 at the Baseline Visit of the study.
•Subjects must have a diagnosis of Posttraumatic Stress Disorder as defined by DSM-IV and determined by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).

Exclusion Criteria

•Subjects whose trauma is ongoing, or who are living in the same home as their abuser, or who are expected to participate in litigation related to their trauma during the course of the study will be excluded from participation.
•Subjects who are likely to or are at high risk for experiencing re-exposure to their index trauma.