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

This study has been terminated.
(Please see Detailed Description below for termination reason.)
Information provided by:
Pfizer Identifier:
First received: September 6, 2005
Last updated: August 16, 2007
Last verified: August 2007
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.

Condition Intervention Phase
Stress Disorders, Post-Traumatic
Drug: Zoloft (Sertraline)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Measures:
  • 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)

Estimated Enrollment: 160
Study Start Date: November 2002
Study Completion Date: July 2007
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.

Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00150306

  Show 23 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00150306     History of Changes
Other Study ID Numbers: A0501061
Study First Received: September 6, 2005
Last Updated: August 16, 2007

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs processed this record on April 25, 2017