Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol: A Randomized Placebo-controlled Trial. PPP
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Child Post-Traumatic Stress Reaction Index/CPTS-RI
研究概览
简要总结
By age 18, roughly 8% of traumatized youth have met criteria for a diagnosis of PTSD, with numbers rising up to 40% in cases of sexual abuse and assault. To date there is no empirical support for the use of psychopharmacological interventions as treatment of pediatric PTSD. Trauma-focused psychotherapeutic/TFP approaches should be favored in childhood PTSD. However, when compared to active control conditions, TFP produced a mean effect size on child and adolescents population (g=0.83). Moreover, in therapies with a substantial exposure component, the intense and lengthy reexperiencing of the traumatic event results in a substantial proportion of participants dropping out.
The reactivation of a previously consolidated memory can make it labile, subsequently requiring a re-stabilization of it called reconsolidation of the memory.
Acting on these reconsolidation processes makes possible to interfere with the subsequent storage of this memory.
详细描述
By age 18, roughly 8% of traumatized youth have met criteria for a diagnosis of PTSD, with numbers rising up to 40% in cases of sexual abuse and assault. To date there is no empirical support for the use of psychopharmacological interventions as treatment of pediatric PTSD. Trauma-focused psychotherapeutic/TFP approaches should be favored in childhood PTSD. However, when compared to active control conditions, TFP produced a mean effect size on child and adolescents population (g=0.83). Moreover, in therapies with a substantial exposure component, the intense and lengthy reexperiencing of the traumatic event results in a substantial proportion of participants dropping out.
The reactivation of a previously consolidated memory can make it labile, subsequently requiring a re-stabilization of it called reconsolidation of the memory.
Acting on these reconsolidation processes makes possible to interfere with the subsequent storage of this memory.
The combination of the targeted reactivation of the traumatic memory and the intake of an agent that decreases the reconsolidation can thus disrupt the recall of unwanted memories and thus serve as a treatment for people suffering from traumatic memories, such as in PTSD.
Since stimulation of β-noradrenergic receptors facilitates the consolidation of memories as well as their re-consolidation, an antagonist of these receptors, propranolol, has generated considerable interest as a treatment to alleviate emotional and traumatic memories in individuals with PTSD.
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
- Double (Participant, Investigator)
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
- •Children aged 7-12 years
- •CPTS-RI total score ≥40
- •Primary diagnosis of PTSD (6 months or more after the traumatic event)
- •Heart rate ≥ 55 bpm
- •Systolic blood pressure ≥ 95 mm Hg
- •Affiliation to a social security scheme
- •Written consent signed by the parents/holders of parental authority and the investigator
- •Acceptance of the protocol by the child-Child and Parents/Holders of parental authority fluent in French
排除标准
- •Age<7 years or ≥13 years
- •Children whose parents have been deprived of their authority
- •Contraindication to propranolol (cardiogenic shock, sinus bradycardia, hypotension (< fifth percentile oscillometric or <2SD) (Banker et al., 2016 - see APPENDIX 1), greater than first-degree heart block, heart failure, bronchial asthma and hypersensitivity to propranolol hydrochloride)
- •Concurrent medication with possible interactions with propranolol (cf 8.2)
- •Concurrent psychotropic drugs that have been shown to be effective in improving symptoms of PTSD (Antidepressants, atypical antipsychotics, mood stabilizers)
- •Concurrent psychotherapy (>1 structured session/month declared by the clinician who follows the child)
- •Current active psychosis, anorexia nervosa, bulimia nervosa, binge-eating disorder, attention-deficit hyperactivity disorder, autism spectrum disorder
- •Children with psoriasis
- •Children with a predisposition to hypoglycemia
- •Obsessive-compulsive disorders
- •Bipolar Disorders
- •Mental retardation,
- •Traumatic brain injury (loss of consciousness > 10 minutes)
- •Currently treated with a bradycardic drug
- •Concurrent participation to another interventional study
- •Renal or Hepatic Impairment
- •Pregnancy
研究组 & 干预措施
Propranolol
Patient will receive oral propranolol
干预措施: Propranolol Oral Product (Drug)
Propranolol
Patient will receive oral propranolol
干预措施: memory reactivation (Other)
Placebo
Patient will receive oral placebo
干预措施: Placebo (Drug)
Placebo
Patient will receive oral placebo
干预措施: memory reactivation (Other)
结局指标
主要结局
Child Post-Traumatic Stress Reaction Index/CPTS-RI
时间窗: week 8
The main evaluation criterion will be the difference between the Child Post-Traumatic Stress Reaction Index/CPTS-RI total score administered at week 8 and week 0. The CPTS-RI is a scale comprised of 20 Likert-type items, intended for children from 6 to 16 years, which evaluates the symptoms of PTSD after exposure to various traumatic events. Each item frequency is rated on a 5-point scale, from never (=0) to almost always (=4). The global score consists of the sum of the 20 items and ranges from 0 to 80, with higher scores indicating higher PTSD symptom severity. The time required for completion of the scale is 15-20 min. A total score of 12-24 is associated with a mild level of PTSD, from 25-39 with a moderate level, from 40-59 with a severe level, and ≥60 with a very severe level.
次要结局
- Children Depression Inventory/CDI total score - Week 32(week 32)
- Children Depression Inventory/CDI total score - Week 60(week 60)
- Children's Sleep Habits Questionnaire/CSHQ Parent version total score(week 8)
- Children's Sleep Habits Questionnaire/CSHQ Parent version total score - Week 32(week 32)
- Child PTSD Checklist-Parent version/CPC-P total score(Week 8)
- Children's Sleep Habits Questionnaire/CSHQ Parent version total score - Week 60(week 60)
- Comorbidity of other mental disorders(week 8)
- Corsi Blocks task(week 8)
- CGAS Children's Global Assessment Scale total score(week 32)
- CGAS Children's Global Assessment Scale total score - Week 60(week 60)
- Child PTSD Checklist-Child version/CPC-C total score(Week 8)
- Child PTSD Checklist-Child version/CPC-C total score - Week 60(Week 60)
- Child PTSD Checklist-Parent version/CPC-P total score - Week 32(Week 32)
- Child PTSD Checklist-Parent version/CPC-P total score - Week 60(Week 60)
- Child Post-Traumatic Stress Reaction - Week 32 Index/CPTS-RI(week 32)
- Child Post-Traumatic Stress Reaction - Week 60 Index/CPTS-RI(week 60)
- Child PTSD Checklist-Child version/CPC-C total score - Week 32(Week 32)
- Kiddie-SADS-Present and Lifetime Version DSM-5/K-SADS-PL-DSM5(week 8)
- Current diagnosis of PTSD at Week 32(week 32)
- Children Depression Inventory/CDI total score(week 8)