A Study of Sertraline to Prevent PTSD

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Sertraline

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