At a glance
ClinicalIndex Comparison Record- ✓Age 6–20 years
- ✓Admission to Shriners Hospital or Massachusetts General Hospital for acute burn, injury, or reconstructive surgery following a burn
- ✓Recent experience of acute burn, injury, or surgery meeting DSM-IV A1 stressor criterion
- ✓Child's response to stressor meets DSM-IV A2 response criterion
- ✕No memory of the injury
- ✕Current use of an antidepressant
- ✕Known hypersensitivity to sertraline
- ✕Diagnosis of Bipolar Disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study of Sertraline to Prevent PTSD
In Brief
A Phase 4 clinical trial evaluating Placebo and Sertraline for Posttraumatic Stress Disorder and Depression. Completed, enrolled 26 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.