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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150306
Recruitment Status : Terminated (Please see Detailed Description below for termination reason.)
First Posted : September 8, 2005
Last Update Posted : August 17, 2007
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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.

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

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : November 2002
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. Secondary efficacy measures include
  2. Child Stress Disorder Checklist (CSDC)
  3. Clinical Global Impression Severity (CGI-S)
  4. Clinical Global Impression Improvement (CGI-I)
  5. Children's Depression Rating Scale - Revised edition (CDRS-R)

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150306

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00150306     History of Changes
Other Study ID Numbers: A0501061
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: August 17, 2007
Last Verified: August 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