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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00150306
• Other study ID #: A0501061
• Status: Terminated
• Phase: Phase 3
• Start date: November 2002
• Est. completion date: July 2007

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Zoloft (Sertraline)

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Baton Rouge	Louisiana
United States	Pfizer Investigational Site	Bethesda	Maryland
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Galveston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lebanon	New Hampshire
United States	Pfizer Investigational Site	Lyndhurst	Ohio
United States	Pfizer Investigational Site	Manhasset	New York
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Marcos	California
United States	Pfizer Investigational Site	Scottsdale	Arizona
United States	Pfizer Investigational Site	Stony Brook	New York
United States	Pfizer Investigational Site	Terre Haute	Indiana
United States	Pfizer Investigational Site	Washington	District of Columbia

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy parameter is the University of California at Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I).
Secondary	Secondary efficacy measures include
Secondary	Child Stress Disorder Checklist (CSDC)
Secondary	Clinical Global Impression Severity (CGI-S)
Secondary	Clinical Global Impression Improvement (CGI-I)
Secondary	Children's Depression Rating Scale - Revised edition (CDRS-R)

External Links

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