Trials Sponsors Conditions Drugs Pricing

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (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 Outcomes (5)

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)

Interventions

Zoloft (Sertraline)Drug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

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).

Sponsors & Collaborators

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

Study Sites (23)

Pfizer Investigational Site

Scottsdale, Arizona, 85281, United States

Pfizer Investigational Site

Sacramento, California, 95817, United States

Pfizer Investigational Site

San Diego, California, 92111, United States

Pfizer Investigational Site

San Marcos, California, 92078, United States

Pfizer Investigational Site

Washington D.C., District of Columbia, 20010, United States

Pfizer Investigational Site

Gainesville, Florida, 32611, United States

Pfizer Investigational Site

Indianapolis, Indiana, 46202-5200, United States

Related Publications (1)

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.
PMID: 21186964DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

November 2002

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

July 2007

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (23)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (23)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations