Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Behaviour as assessed by score variations in specific questionaries
研究概览
简要总结
The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prader-Willi syndrome genetically confirmed
- •Absence of extension of the QT interval in the electrocardiogram
- •Absence of hypokalemia
排除标准
- •Psychiatric troubles
- •Anomalies of the heart rhythm in significant ECG
- •Hepatic insufficiency
- •Renal insufficiency
- •Patients presenting a pregnancy or breast-feeding
- •High sensibility to OT
- •High sensibility to the excipients of the product
- •Patients having family history of genetic pathology causing an extension of the interval QT
- •Patients having risk factors of advanced twist
研究组 & 干预措施
placebo daily
daily administration of placebo during 28 days : placebo continuous
干预措施: Placebo continuous (Drug)
24 IU of oxytocin daily
24 IU of daily oxytocin administration during 28 days : oxytocin continuous
干预措施: Oxytocin (OXT) continuous (Drug)
24 IU of oxytocin every 3 days
24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days
干预措施: Placebo (Drug)
24 IU of oxytocin every 3 days
24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days
干预措施: Oxytocin (Drug)
结局指标
主要结局
Change in Behaviour as assessed by score variations in specific questionaries
时间窗: Every day before and after administration of treatment during 28 days
Change in eating Behaviour as assessed by score variations in specific questionaries
时间窗: Every day before and after administration of treatment during 28 days
次要结局
- Change in eating behaviour as assessed by score variations in hunger visual analogic scale(Every day before and after administration of treatment during 28 days)
- Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan)(Day 1, day 2 and day 30)
- Evaluation of social skills assessed by specific questionnaires(Day 1, day 2 and day 30)
- Social processing assessed by oculomotor exploration(Day 1, day 2 and day 30)
- Multisensory processing assessed by Neurovisual task(Day 1, day 2 and day 30)
- Hormon blood concentration levels as assessed by bioassays(Day 2 and day 30)
- Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI)(Day 1, day 2 and day 29)
- Evaluation of executive function assessed by specific questionnaires(Day 1, day 2 and day 30)
- Evaluation of theory of mind assessed by specific questionnaires(Day 1, day 2 and day 30)