A Ten-Week Study Evaluating The Effectiveness And Safety Of Zoloft In Children And Adolescents With A Diagnosis Of PTSD
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD)|
- The primary efficacy parameter is the University of California at Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I).
- 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)
|Study Start Date:||November 2002|
|Study Completion Date:||July 2007|
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.
Show 23 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|