Pharmacologic Treatment of PTSD in Sexually Abused Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Allegheny Singer Research Institute
ClinicalTrials.gov Identifier:
NCT00078767
First received: March 5, 2004
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

This study will evaluate the benefit of adding sertraline (Zoloft®) to trauma-focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD).


Condition Intervention Phase
Stress Disorders, Post-Traumatic
Child Abuse, Sexual
Drug: Trauma-focused Cognitive Behavioral Therapy plus Sertraline
Drug: Trauma-focused Cognitive Behavioral Therapy plus Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allegheny Singer Research Institute:

Estimated Enrollment: 60
Study Start Date: April 2001
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal). No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents. Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents. Many children and youth with PTSD are currently prescribed SSRIs and other medications. This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD. If adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Children and adolescents ages 10-18 years old who have PTSD related to sexual abuse which has been independently verified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078767

Locations
United States, Pennsylvania
Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Allegheny Singer Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00078767     History of Changes
Other Study ID Numbers: K02 MH01938, K02MH001938, DDTR BC-CB
Study First Received: March 5, 2004
Last Updated: November 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Allegheny Singer Research Institute:
PTSD
Depression
Anxiety

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014