A Study of Sertraline to Prevent PTSD
Condition: Posttraumatic Stress Disorder; Depression
MeSH terms: Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Placebo; Sertraline
Intervention description: The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinued.; The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 6 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: sertraline; children; adolescents; posttraumatic stress disorder; depression; prevention; burns; injuries

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-burn injury. This study is investigating the early use of a
      medication in the prevention of posttraumatic stress disorder and depression. Specific Aims 1
      and 2: To assess the efficacy of sertraline to prevent the development of (Aim
      1)posttraumatic stress disorder and (Aim 2)depression in children aged 6-20, after burn or
      non-burn injury or after reconstructive surgery. Hypotheses 1 and 2: Administration of
      sertraline after an acute burn or non-burn injury, or after reconstructive surgery will lead
      to greater reduction in post-traumatic and depressive symptoms over 12 and 24 weeks, compared
      with placebo.

      This study is completing the evaluation of 90 children and adolescents, aged 6-20 years. It
      is comparing 60 subjects receiving sertraline with 30 placebo control subjects matched for
      age, severity of injury, and type of hospitalization (acute vs. reconstructive). Children and
      families are evaluated for the presence of acute stress symptoms. Children are reassessed in
      a double-blind placebo-controlled design, with evaluations at Baseline, Week 2, Week 4, Week
      8, Week 12, and Week 24. In addition, there is weekly monitoring for the first 14 weeks of
      the study and again at 18 weeks (the midpoint of the study). At each reassessment,
      information is collected on the child's compliance with the study medication, the parents'
      assessment of the child's functioning, and the child's self-report of posttraumatic and
      depressive symptomatology. The main outcome variable used in this study is the child's
      posttraumatic symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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