OXYTOCIN SYNTHETIC for Autism spectrum disorder

Inclusion criteria

• {"criterion_text":"- 1.\tMale and female participant between the ages of 12 and 21, both inclusive\n- 1.\tParticipants 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.\n- 2.\tParticipants must have a confirmed diagnosis of autism spectrum disorder (ASD)"}

Exclusion criteria

• {"criterion_text":"- Previous nasal disease, surgery, and dependence on inhaled drugs\n- Full scale IQ below 70 (due to the prerequisite ability to complete self-report measures)\n- Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at the experimental sessions for all menstruating individuals)\n- Currently breastfeeding\n- Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrolment\n- Current significant nasal congestion due to common colds\n- Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder\n- Epilepsy and previous history of photosensitive seizures\n- Systemic illness requiring treatment within 2 weeks prior to Study Day 1\n- 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\n- Known allergic reactions or hypersensitivity/intolerance to latex\n- 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\n- Participation in any (other) clinical trial with an investigational medicinal product or medical device within 1 month prior to randomization"}

Primary endpoints

• {"endpoint_text":"- Neural plasticity will be evaluated using EEG 40 minutes after intervention administration. The visual evoked potential (VEP) paradigm will be used to probe neural plasticity. An increase in neural plasticity will be measured by a statistically significant amplitude modulation when compared to placebo in the following components: C1, P1, N1, N1b and P2. H1: There is a difference between placebo and active treatments. H0: There is no significant difference between placebo and active treatments.","definition_or_measurement_approach":"Evaluated using EEG 40 minutes after administration using the visual evoked potential (VEP) paradigm; increase measured by statistically significant amplitude modulation in components C1, P1, N1, N1b and P2 compared to placebo."}
• {"endpoint_text":"- Cognitive flexibility will be evaluated behaviourally using the computerized probabilistic reversal learning task. An increase in task performance is measured as a statistically significant decrease in number of incorrect trials and total number of trials needed to reach the learning criterion. H1: There is a difference between placebo and active treatments. H0: There is no significant difference between placebo and active treatments).","definition_or_measurement_approach":"Measured using the computerized probabilistic reversal learning task; improvement defined as a statistically significant decrease in number of incorrect trials and total number of trials needed to reach the learning criterion compared to placebo."}

Secondary endpoints

• {"endpoint_text":"- Heart rate variability (HRV), measured using electrocardiogram (ECG) 60 minutes after intervention administration. H1: There is a difference in HRV between placebo and active treatments. H0: There is no significant difference in HRV between placebo and active treatments)","definition_or_measurement_approach":"HRV measured using ECG 60 minutes after intervention administration; comparison between active and placebo."}
• {"endpoint_text":"- The potential moderating effect on intervention response of symptom severity, as indexed by the Social Responsiveness ScaleSecond Edition, Repetitive Behaviour ScaleRevised, Behavioral Inflexibility scale and The Autism Behaviour Inventory. H1: Higher disorder severity will be associated with increased oxytocin treatment response. H0: H0: There is no significant positive association between disorder severity with oxytocin treatment response.","definition_or_measurement_approach":"Moderator analysis using symptom severity indices: Social Responsiveness Scale Second Edition, Repetitive Behaviour Scale-Revised, Behavioral Inflexibility scale, and The Autism Behaviour Inventory to assess association with treatment response."}

Methods

• Document titled 'AD poster for clinics' (recruitment via clinic posters / advertising in clinical settings) — document present but content not extracted
• Document titled 'K1_ Recruitment Arrangements' (recruitment arrangements document present for the Norway part; details not extracted)

Norway

Earliest CTIS Part Ii Submission Date

29-04-2024

Latest Decision Or Authorization Date

03-12-2025

Processing Time Days

583

Number Of Sites

1

Number Of Participants

98

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"","full_name":"Helse Sør-Øst RHF","duties_or_roles":"Source of monetary support","organisation_type":""}