Status:
COMPLETED
Pharmacologic Treatment of PTSD in Sexually Abused Children
Lead Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
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 c...
Eligibility Criteria
Inclusion
- Inclusion:
- Ages 10-17 years, inclusive
- Confirmed sexual abuse
- At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal)
- Parent/primary caregiver available to participate in treatment
- Assent with parental consent to participate
- Exclusion:
- Non-English speaking
- schizophrenia or other severe psychotic disorder
- MR (IQ\<60) or PDD preventing CBT treatment
- taking current psychotropic medication
- documented substance dependence (substance abuse allowed)
Exclusion
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00078767
Start Date
April 1 2001
End Date
March 1 2006
Last Update
April 5 2017
Active Locations (1)
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1
Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents
Pittsburgh, Pennsylvania, United States, 15212