Pharmacologic Treatment of PTSD in Sexually Abused Children - Tabular View

Tracking Information
First Received Date ^ICMJE	March 5, 2004
Last Updated Date	February 12, 2008
Start Date ^ICMJE	April 2001
Primary Completion Date	March 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00078767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Pharmacologic Treatment of PTSD in Sexually Abused Children
Official Title ^ICMJE
Brief Summary	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).
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Stress Disorders, Post-Traumatic Child Abuse, Sexual
Intervention ^ICMJE	Drug: Trauma-focused Cognitive Behavioral Therapy plus Sertraline Drug: Trauma-focused Cognitive Behavioral Therapy plus Placebo
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	March 2006
Primary Completion Date	March 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Children and adolescents ages 10-18 years old who have PTSD related to sexual abuse which has been independently verified
Gender	Both
Ages	10 Years to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00078767
Responsible Party
Study ID Numbers ^ICMJE	K02 MH01938, DDTR BC-CB
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP