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

Stopped early · Phase 3

Conditions studied: Stress Disorders, Post-Traumatic

In brief

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.

Key facts

Study ID

NCT00150306

Run by

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

People needed

160

Starts

2002-11-01

Expected to finish

2007-07-01

Last updated by the study team

2021-01-29

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Scottsdale, Arizona, 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 — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Terre Haute, Indiana, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Baton Rouge, Louisiana, United States
• Pfizer Investigational Site — New Orleans, Louisiana, United States
• Pfizer Investigational Site — Bethesda, Maryland, United States
• Pfizer Investigational Site — Las Vegas, Nevada, United States
• Pfizer Investigational Site — Lebanon, New Hampshire, United States
• Pfizer Investigational Site — Manhasset, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Stony Brook, New York, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Lyndhurst, Ohio, United States
• Pfizer Investigational Site — Charleston, South Carolina, United States
• Pfizer Investigational Site — Galveston, Texas, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — Plano, Texas, United States

Full record on ClinicalTrials.gov

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