A randomized, placebo-controlled, double-blind, 3-period cross-over study in youth with autism spectrum disorders evaluating neural plasticity and learning after a single administration of intranasal oxytocin

Oslo University Hospital HF0 个研究点目标入组 98 人开始时间: 2024年2月15日最近更新: 2024年7月22日

适应症

试验速览

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•1.Male and female participant between the ages of 12 and 21, both inclusive, 1.Participants and their caregivers (if applicable) must be able to communicate with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information., 2.Participants must have a confirmed diagnosis of autism spectrum disorder (ASD)

•Previous nasal disease, surgery, and dependence on inhaled drugs, Full scale IQ below 70 (due to the prerequisite ability to complete self-report measures), Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at the experimental sessions for all menstruating individuals), Currently breastfeeding, Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrolment, Current significant nasal congestion due to common colds, Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder, Epilepsy and previous history of photosensitive seizures, Systemic illness requiring treatment within 2 weeks prior to Study Day 1, 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, New concomitant medications or formal cognitive/behavioural therapies. If a participant has been taking any medications or receiving formal cognitive/behavioural therapies for at least 4 weeks, then this is not considered a new therapy, Participation in any (other) clinical trial with an investigational medicinal product or medical device within 1 month prior to randomization

发起方

Oslo University Hospital HF