DRKS00008984招募中3 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-Universität Marburg vertreten durch das Koordinierungszentrum für Klinische Studien0 个研究点目标入组 72 人开始时间: 2015年8月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 15 Years 至 35 Years（—）
- 性别
- Male
入选标准
- •Diagnosis of childhood autism (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
- •- genotyped SNP rs53576 in the oxytocin receptor gene
- •- Signed form of consent (for underage persons: legal guardian)
排除标准
- •- 18 = BMI = 30
- •- IQ < 70
- •- traumatic lesions of the brain
- •- serious neurologic diseases (e.g. epilepsy)
- •- metal implants
- •- acute suicidal tendency according to the clinical impression
- •- metabolic or endocrinologic disorders stated in the case history
- •- cardiovascular disorders (anamnesis, electrocardiogram, blood pressure and pulse): 50 = heart rate (bpm) = 90, 100 = blood pressure systolic (mmHg) = 140; 60 = blood pressure diastolic (mmHg) = 90
- •- hypersensitivity to nasal sprays or other drugs stated in the case history
- •- comorbid drug, alcohol or nicotine (no more than 15 cigarettes per day) abuse or addiction
- •- intake of food, coffee, beverages (except water), nicotin-consumption as well as excessive fluid intake within the 2 hours before the application of oxytocin/placebo
- •- common cold
研究者
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