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. )

First Received on September 6, 2005. Last Updated on August 16, 2007 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00150306

Purpose

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

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.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150306

Show 23 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00150306 History of Changes
Other Study ID Numbers:	A0501061
Study First Received:	September 6, 2005
Last Updated:	August 16, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 07, 2012