Autism spectrum disorders
Conditions
Interventions
Trade Name: Syntocinon
Pharmaceutical Form: Nasal spray
INN or Proposed INN: OXYTOCIN
CAS Number: 50-56-6
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female participants between the ages of 12 and 20, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis 2. Participants must be in good general physical health, as determined by the investigator. 3. Participant’s pre-study physical examination and vital signs must not show any clinically significant abnormalities as determined by the investigator. 4. Participants and caregivers 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 study information Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participants with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder. 2. Somatic illness requiring treatment within 2 weeks prior to Study Day 1. 3. Full scale IQ < 70 (due to the prerequisite ability to complete self-report measures). 4. 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. 5. Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at Experimental session 1 and 2 for all menstruating females) 6. Participation in any other clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation. 7. Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participant unsuitable for enrollment
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Behavioral inflexibility after four weeks of treatment assessed with the Behavioral Inhibition scale (BIS), completed by caregivers of the participants o Social cognition assessed by a computerized Emotional body language task, completed by the participants o Repetitive cognition will be assessed by a probabilistic reversal task, completed by research participant o Heart rate variability, measured using electrocardiogram (ECG) ;Timepoint(s) of evaluation of this end point: Four weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to identify effects of 24 IU oxytocin delivered intranasally twice-daily for four weeks on measures of social and repetitive behaviors compared to placebo in youth diagnosed with ASD.;Secondary Objective: •To identify effects of 24 IU oxytocin delivered intranasally twice-daily for four weeks on behavioral inflexibility in ASD patients •To identify effects of 24 IU oxytocin delivered intranasally twice-daily for four weeks on performance in lab-based cognitive tasks in ASD patients •Document safety (adverse event profile) of 24 IU oxytocin delivered intranasally twice-daily for four weeks in ASD patients ;Primary end point(s): The primary endpoints are measures of social and repetitive behavior: oSocial behavior after four weeks of treatment assessed with the total score of the Social Responsiveness Scale-Second Edition (SRS-2), completed by caregivers of the participants oRepetitive behaviour after four weeks of treatment assessed with the Repetitive Behavior Scale-Revised (RBS-R), completed by caregivers of the participants ;Timepoint(s) of evaluation of this end point: Four weeks | — |
Countries
Norway
Contacts
Public ContactTerje Nærland
Oslo University Hospital
Outcome results
None listed