EUCTR2012-003750-89-DE进行中（未招募）1 期
A placebo-controlled, double blind, randomised trial with crossover-design investigating the effect of oxytocin nasal spray on neuronal processes of empathy - empathy-autism-oxytocin
Philipps-University Marburg0 个研究点目标入组 72 人开始时间: 2012年11月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Diagnosis of autistic disorder (F84.0 according to ICD-10), Asperger syndrome (F84.5 according to ICD-10), atypical autism (F84.1 according to ICD-10)
- •Male patients
- •Age 15 = years = 35
- •German as native language
- •Right-handedness ( Edinburgh Inventory of Handedness; Oldfield, 1971)
- •genotyped SNP rs53576 in the oxytocin receptor gene
- •Signed form of consent (for underage persons: legal guardian)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 49
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •18 = BMI = 30
- •traumatic lesions of the brain
- •serious neurologic diseases (e.g. epilepsy)
- •incorporated metal
- •acute suicidal tendency according to the clinical impression
- •anamnestic known metabolic or endocrinologic disorders
- •cardiac disorders (anamnesis, electrocardiogram, blood pressure and pulse): 50 = heart rate (bpm) = 90, 100 = blood pressure systolic (mmHg) = 140; 60 = blood pressure diastolic (mmHg) = 90
- •anamnestic known hypersensitivity to nasal sprays or other drugs
- •comorbid drug, alcohol or nicotine (no more than 15 cigarettes per day) abuse or dependence
- •within the 2 hours before the application of oxytocin/placebo intake of food, coffee, beverages (except water), nicotin-consumption as well as excessive fluid intake
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