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

Condition(s) targeted: Stress Disorders, Post-Traumatic

Intervention: Zoloft (Sertraline) (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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:

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)

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.

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

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.

Pfizer Investigational Site, Scottsdale, Arizona 85281, United States

Pfizer Investigational Site, SAN DIEGO, California 92111, United States

Pfizer Investigational Site, SAN MARCOS, California 92078, United States

Pfizer Investigational Site, Sacramento, California 95817, United States

Pfizer Investigational Site, Washington, District of Columbia 20010, United States

Pfizer Investigational Site, GAINESVILLE, Florida 32611, United States

Pfizer Investigational Site, INDIANAPOLIS, Indiana 46202-5200, United States

Pfizer Investigational Site, Terre Haute, Indiana 47802, United States

Pfizer Investigational Site, Overland Park, Kansas 66214, United States

Pfizer Investigational Site, Baton Rouge, Louisiana 70816, United States

Pfizer Investigational Site, New Orleans, Louisiana 70112, United States

Pfizer Investigational Site, BETHESDA, Maryland 20814, United States

Pfizer Investigational Site, Las Vegas, Nevada 89128, United States

Pfizer Investigational Site, LEBANON, New Hampshire 03756-0002, United States

Pfizer Investigational Site, New York, New York 10016, United States

Pfizer Investigational Site, MANHASSET, New York 11030, United States

Pfizer Investigational Site, Stony Brook, New York 11794, United States

Pfizer Investigational Site, Cleveland, Ohio 44106, United States

Pfizer Investigational Site, Lyndhurst, Ohio 44124, United States

Pfizer Investigational Site, CHARLESTON, South Carolina 29425, United States

Pfizer Investigational Site, GALVESTON, Texas 77555-0188, United States

Pfizer Investigational Site, Houston, Texas 77058, United States

Pfizer Investigational Site, Plano, Texas 75024, United States

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting

Starting date: November 2002
Ending date: July 2007
Last updated: August 16, 2007