Clinical Trial: Pharmacologic Treatment of PTSD in Sexually Abused Children

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

This study is evaluating the benefit of adding sertraline (Zoloft) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD). Sixty of these children ages 10-18 years, will be randomly assigned to receive 12 weeks of TF-CBT plus sertraline versus TF-CBT lus placebo. In addition to evaluating PTSD symptoms during the course of treatment, depressive and anxiety symptoms, functional impairment, medication side effects, parental emotional distress and support of the child, and the child's sexual abuse-related cognitions will be assessed at pre- and post-treatment.

Condition Treatment or Intervention Phase
Posttraumatic Stress Disorder
Major Depressive Disorder
Anxiety Disorders
 Drug: Trauma-focused Cognitive Behavioral Therapy plus Sertraline
 Drug: Trauma-focused Cognitive Behavioral Therapy plus Placebo
Phase III

MedlinePlus related topics:  Anxiety;   Mental Health;   Post-Traumatic Stress Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  60

Study start: April 2001;  Expected completion: March 2006

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   -   18 Years,  Genders Eligible for Study:  Both

Criteria

  • Children and adolescents ages 10-18 years old who have PTSD related to sexual abuse which has been independently verified

Location and Contact Information


Pennsylvania
      Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents, Pittsburgh,  Pennsylvania,  15212,  United States; Recruiting
Judith A Cohen, M.D.  412-330-4321    jcohen1@wpahs.org 
Carrie Seslow, MSW  412-330-4328    cseslow@wpahs.org 
Judith A Cohen, M.D.,  Principal Investigator

More Information

National Child Traumatic Stress Network

Study ID Numbers:  K02 MH1938
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  March 5, 2004
ClinicalTrials.gov Identifier:  NCT00078767
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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