NCT00150306

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_3

Geographic Reach
1 country

23 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

First QC Date

September 6, 2005

Last Update Submit

January 26, 2021

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

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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Pfizer Investigational Site

Scottsdale, Arizona, 85281, United States

Location

Pfizer Investigational Site

Sacramento, California, 95817, United States

Location

Pfizer Investigational Site

San Diego, California, 92111, United States

Location

Pfizer Investigational Site

San Marcos, California, 92078, United States

Location

Pfizer Investigational Site

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

Location

Pfizer Investigational Site

Gainesville, Florida, 32611, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46202-5200, United States

Location

Pfizer Investigational Site

Terre Haute, Indiana, 47802, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66214, United States

Location

Pfizer Investigational Site

Baton Rouge, Louisiana, 70816, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70112, United States

Location

Pfizer Investigational Site

Bethesda, Maryland, 20814, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89128, United States

Location

Pfizer Investigational Site

Lebanon, New Hampshire, 03756-0002, United States

Location

Pfizer Investigational Site

Manhasset, New York, 11030, United States

Location

Pfizer Investigational Site

New York, New York, 10016, United States

Location

Pfizer Investigational Site

Stony Brook, New York, 11794, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106, United States

Location

Pfizer Investigational Site

Lyndhurst, Ohio, 44124, United States

Location

Pfizer Investigational Site

Charleston, South Carolina, 29425, United States

Location

Pfizer Investigational Site

Galveston, Texas, 77555-0188, United States

Location

Pfizer Investigational Site

Houston, Texas, 77058, United States

Location

Pfizer Investigational Site

Plano, Texas, 75024, United States

Location

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

Related Links

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, CyclicHydrocarbonsPolycyclic Compounds

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 1, 2002

Study Completion

July 1, 2007

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

US(23)