Status:
COMPLETED
A Study of Sertraline to Prevent PTSD
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Posttraumatic Stress Disorder
Depression
Eligibility:
All Genders
6-20 years
Phase:
PHASE4
Brief Summary
The broad, long-term objectives of this proposal are to prevent the emergence of posttraumatic stress and depressive symptoms in children admitted for an acute burn, reconstructive surgery, or non-bur...
Detailed Description
RESEARCH DESIGN AND METHODS 1. SPECIFIC AIM 1: To assess the efficacy of sertraline in preventing posttraumatic stress disorder in children aged 6-20 after a burn, injury or reconstructive surgery fo...
Eligibility Criteria
Inclusion
- Admission to the Shriners Hospital or Massachusetts General Hospital for an acute burn, injury, or reconstructive surgery following a burn
- Between the ages of 6 - 20 years
- Recent experience of an acute burn, injury, or surgery meeting the Diagnostic and Statistical Manual(DSM-IV) A1 stressor criterion
- Child's response to the stressor meets Diagnostic and Statistical Manual(DSM-IV) A2 response criterion
- Proficiency in either English or Spanish
Exclusion
- No memory of the injury
- Current use of an anti-depressant
- Known hypersensitivity to sertraline
- Diagnosis of Bipolar Disorder
- Diagnosis of PTSD
- Mental Retardation
- Traumatic Brain Injury
- New onset or marked worsening of a seizure disorder
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00182078
Start Date
November 1 2002
End Date
July 1 2006
Last Update
August 5 2014
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114