A randomized, placebo-controlled, double-blind, 2-period cross-over study in youth with autism spectrum disorders evaluating social and repetitive behaviors after four weeks of twice daily-doses of 24IU of intranasally administered oxytocin
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on social behavior. This will be operationalized as change from baseline on performance on the Social Responsiveness Scale-Second Edition (SRS-2), completed by caregivers of the participants.
研究概览
简要总结
The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on social behavior and repetitive behavior.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female participant between the ages of 12 and 20, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) using the Autism Diagnostic Observation Schedule (ADOS).
- •Participants must be in good general physical health, as determined by the investigator.
- •Participants must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information.
- •Provision of a signed, written informed consent, if 16 years and older. Participants between the ages of 12 and 15 (inclusive) will provide assent, with caregivers providing consent. Caregivers will also provide consent for research participation.
排除标准
- •Previous nasal disease, surgery, and dependence on inhaled drugs.
- •Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation.
- •New concomitant medications or formal cognitive/behavioral therapies. If a participant has been taking any medications or receiving formal cognitive/behavioral therapies for at least 4 weeks, then this is not considered a new therapy.
- •Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrollment.
- •Current significant nasal congestion due to common colds.
- •Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.
- •Systemic illness requiring treatment within 2 weeks prior to Study Day
- •Full scale IQ < 70 (due to the prerequisite ability to complete self-report measures).
- •Known allergic reactions or hypersensitivity to any component of the study medication in the nasal spray, such as propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218) and chlorobutanol hemihydrate.
- •Known allergic reactions or hypersensitivity/intolerance to latex.
- •Currently breastfeeding.
- •Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at Experimental session 1 and 3 for all menstruating females).
结局指标
主要结局
The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on social behavior. This will be operationalized as change from baseline on performance on the Social Responsiveness Scale-Second Edition (SRS-2), completed by caregivers of the participants.
The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on social behavior. This will be operationalized as change from baseline on performance on the Social Responsiveness Scale-Second Edition (SRS-2), completed by caregivers of the participants.
The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on repetitive behavior. This will be operationalized as change from baseline on performance on the Repetitive Behavior Scale-Revised (RBS-R) scale, completed by caregivers of the participants.
The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on repetitive behavior. This will be operationalized as change from baseline on performance on the Repetitive Behavior Scale-Revised (RBS-R) scale, completed by caregivers of the participants.
次要结局
- The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on behavioral inflexibility. This will be operationalized as change from baseline on performance on the Behavioral Inflexibility scale (BIS), completed by caregivers of the research participants
研究者
Daniel S. Quintana
Scientific
Oslo University Hospital HF