Clinical trial NCT00150306: A Ten-Week Study Evaluating The Effectiveness And Safety Of Zoloft In Children And Adolescents With A Diagnosis Of PTSD
Official title: A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: 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:
measure: Secondary efficacy measures include
measure: Child Stress Disorder Checklist (CSDC)
measure: Clinical Global Impression Severity (CGI-S)
measure: Clinical Global Impression Improvement (CGI-I)
measure: Children's Depression Rating Scale - Revised edition (CDRS-R)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Marcos
country: United States
facility: Pfizer Investigational Site
state: California
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Terre Haute
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Bethesda
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Manhasset
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lyndhurst
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Galveston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.