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

Phase 3

Terminated

• Conditions: Stress Disorders, Post-Traumatic

• Registration Number: NCT00150306
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Study Completion: 2007-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary efficacy parameter is the University of California at Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I).

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy measures include
Child Stress Disorder Checklist (CSDC)
Clinical Global Impression Severity (CGI-S)
Clinical Global Impression Improvement (CGI-I)
Children's Depression Rating Scale - Revised edition (CDRS-R)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Plano, Texas, United States