Effect of D-cycloserine on Treatment of PTSD in Youth
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Child PTSD Symptom Scale (CPSS)
研究概览
简要总结
The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of posttraumatic stress disorder (PTSD) in 7-12 year old children.
详细描述
While most individuals with PTSD treated with cognitive behavioral therapy (CBT) show improvement, they still have some enduring symptoms and functional impairment. Accordingly, there is a need for treatment advances.
D-cycloserine (DCS), an antibiotic that has been used for over 50 years, has also been found to have positive effects on cognition and anxiety. DCS was found to enhance learning and memory, and also facilitates extinction of fear reactions. However, DCS only produces an extinction effect when paired with behavioral training, not when simply given alone. Thus, the medication only needs to be given for seven doses in this research and youth do not need to take the medication long term. The research also includes a three-month follow-up assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Certain number of PTSD symptoms plus functional impairment
- •Must be able to swallow pills
排除标准
- •Serious kidney or liver disease
- •Psychosis
研究组 & 干预措施
D-cycloserine plus CBT
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
干预措施: D-cycloserine (Drug)
D-cycloserine plus CBT
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
干预措施: CBT (Behavioral)
Placebo plus CBT
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
干预措施: Placebo pill (Drug)
Placebo plus CBT
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
干预措施: CBT (Behavioral)
结局指标
主要结局
Child PTSD Symptom Scale (CPSS)
时间窗: After 12 therapy sessions, up to 28 weeks.
The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).
次要结局
未报告次要终点
研究者
Michael S. Scheeringa
Professor
Tulane University School of Medicine