Status:
TERMINATED
A Ten-Week Study Evaluating The Effectiveness And Safety Of Zoloft In Children And Adolescents With A Diagnosis Of PTSD
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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 end...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00150306
Start Date
November 1 2002
End Date
July 1 2007
Last Update
January 29 2021
Active Locations (23)
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1
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85281
2
Pfizer Investigational Site
Sacramento, California, United States, 95817
3
Pfizer Investigational Site
San Diego, California, United States, 92111
4
Pfizer Investigational Site
San Marcos, California, United States, 92078