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

Last updated on December 17, 2017

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Study Location
Pfizer Investigational Site
Scottsdale, Arizona, 85281 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Post-Traumatic Stress Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00150306
Pfizer
Terminated
A Ten-Week Study Evaluating The Effectiveness And Safety Of Zoloft In Children And Adolescents With A Diagnosis Of PTSD

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A Ten-Week Study Evaluating The Effectiveness And Safety Of Zoloft In Children And Adolescents With A Diagnosis Of PTSD
A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD)
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Stress Disorders, Post-Traumatic
Drug: Zoloft (Sertraline)
Not Provided
Robb AS, Cueva JE, Sporn J, Yang R, Vanderburg DG. Sertraline treatment of children and adolescents with posttraumatic stress disorder: a double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2010 Dec;20(6):463-71. doi: 10.1089/cap.2009.0115.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
July 2007
Not Provided

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.
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00150306
A0501061
No
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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