EUCTR2010-024202-34-DE进行中（未招募）1 期
Effect of oxytocin on therapy results of a group based social skill training in adolescents with Autism Spectrum Disorder - group-therapy-autism-oxytocin
IVERSITÄTSMEDIZIN GÖTTINGEN, GEORG-AUGUST-UNIVERSITÄT,Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie0 个研究点目标入组 210 人开始时间: 2013年12月9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
- 210
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
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 8-18 years
- •German as native language
- •no or stable psychopharmacotherapy
- •signed form of consent (for underage person: legal guardian)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 210
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 21
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •traumatic lesions of the brain
- •obsessive-compulsive disorder
- •social anxiety disorder
- •major depression episode with suicidal ideation
- •aggressive behaviour interfering with group therapy
- •any personality disorder
- •serious neurological disease (e.g. epilepsy)
- •other medical disorder interfering with therapy
- •group based Social skill training during the last 6 months prior to study
- •cardiovascular disease
- •anamnestic known metabolic or endocrinologic disorders
- •anamnestic known hypersensitivity to nasal sprays or other drugs
- •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
- •hypersensitivity to oxytocin
- •(Safety: At the beginning of the study, each participant will receive OXT/Placebo while being monitored for 90 min by a physician. Participants experiencing serious adverse side effects will be excluded from the study. A trained physician will monitor each group-session)
研究者
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