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

Further Study Details: 

Primary Outcomes: 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: 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)
Expected Total Enrollment:  160

Ages Eligible for Study:  6 Years   -   17 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00150306

Jacqueline Wilkes      212-733-8078    Jacqueline.Wilkes@pfizer.com

California
      Pfizer Investigational Site, San Diego,  California,  92111,  United States; Recruiting
      Pfizer Investigational Site, San Marcos,  California,  92078,  United States; Recruiting
      Pfizer Investigational Site, Sacramento,  California,  95817,  United States; Recruiting
District of Columbia
      Pfizer Investigational Site, Washington,  District of Columbia,  20010,  United States; Recruiting
Florida
      Pfizer Investigational Site, Gainesville,  Florida,  32611,  United States; Recruiting
Indiana
      Pfizer Investigational Site, Indianapolis,  Indiana,  46202-5200,  United States; Completed
      Pfizer Investigational Site, Terre Haute,  Indiana,  47802,  United States; Recruiting
Kansas
      Pfizer Investigational Site, Overland Park,  Kansas,  66214,  United States; Completed
Louisiana
      Pfizer Investigational Site, New Orleans,  Louisiana,  70112,  United States; Recruiting
Maryland
      Pfizer Investigational Site, Bethesda,  Maryland,  20814,  United States; No longer recruiting
Nevada
      Pfizer Investigational Site, Las Vegas,  Nevada,  89128,  United States; Recruiting
New Hampshire
      Pfizer Investigational Site, Lebanon,  New Hampshire,  03756-0002,  United States; No longer recruiting
New York
      Pfizer Investigational Site, New York,  New York,  10016,  United States; No longer recruiting
      Pfizer Investigational Site, New York,  New York,  10011,  United States; Recruiting
      Pfizer Investigational Site, Manhasset,  New York,  11030,  United States; Recruiting
      Pfizer Investigational Site, Syracuse,  New York,  13210,  United States; Recruiting
      Pfizer Investigational Site, New York,  New York,  10029,  United States; No longer recruiting
      Pfizer Investigational Site, Stony Brook,  New York,  11794,  United States; Recruiting
Ohio
      Pfizer Investigational Site, Cincinnati,  Ohio,  45219,  United States; Recruiting
South Carolina
      Pfizer Investigational Site, Charleston,  South Carolina,  29425,  United States; Recruiting
Texas
      Pfizer Investigational Site, Galveston,  Texas,  77555-0188,  United States; Recruiting
      Pfizer Investigational Site, Houston,  Texas,  77058,  United States; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A0501061
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00150306
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13