A Study of Sertraline to Prevent PTSD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent
研究概览
简要总结
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.
详细描述
RESEARCH DESIGN AND METHODS
- 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 following a burn injury.
- SPECIFIC AIM 2: To assess the efficacy of sertraline in preventing co-morbid depression in children aged 6-20 after a burn, injury or reconstructive surgery following a burn injury.
BACKGROUND AND SIGNIFICANCE Prevention of posttraumatic stress symptoms is a priority in psychiatric practice today. This is the first controlled study of any medication to prevent posttraumatic stress disorder (PTSD) in children and adolescents. The purpose of the study is to use sertraline to prevent PTSD and co-morbid depression from developing in 6-20 year old children hospitalized with a burn, injury, or reconstructive surgery following a burn injury. If this intervention is successful, it will help to prevent psychiatric and developmental disorders in injured children as well as those who undergo reconstructive procedures. While we have found no studies that have investigated the efficacy of sertraline in treating PTSD in children and adolescents, research indicates that sertraline is effective in treating other anxiety disorders and depression in children and adolescents. Research also indicates that sertraline is effective in treating PTSD in adults.
RECRUITMENT PROCEDURES Families of children aged 6-20 admitted with an acute burn or for reconstructive surgery are contacted by study staff within 3 days of admission or when medically stable, and asked to participate in the study. In addition, 6-17 year old patients admitted for an injury are asked to participate.
CONSENT PROCEDURES: A licensed physician investigator explains the nature of the study and requests consent from the child's primary caregiver or legal guardian as soon as possible after hospital admission. Once consent is given, the research coordinator obtains the baseline data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo was administered on a flexible fixed schedule and tapered at 12 weeks.
干预措施: Placebo (Drug)
Sertraline
Sertraline was administered on a flexible fixed schedule beginning at 25 mg/day and increasing as high as 150 mg/day. At week 12, the medication was tapered at a rate of 25 mg every 3 days until it was discontinued.
干预措施: Sertraline (Drug)
结局指标
主要结局
Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent
时间窗: Baseline to Week 24
The DICA is a semi-structured interview, and was used to measure post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to parents who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.
Diagnostic Interview for Children and Adolescents (DICA) - Child
时间窗: Baseline to Week 24
The DICA is a semi-structured interview, and was used to measure Post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to children who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.
次要结局
- The Child Depression Inventory (CDI)(Baseline to Week 12)
研究者
Frederick J. Stoddard, MD
Principal Investigator
Massachusetts General Hospital