A single-center, randomized, double-blind, placebo-controlled, cross-over study of intranasal oxytocin in young adults with Autism Spectrum Disorder

INTERVENTION: Trade Name: Syntocinon Product Name: Syntocinon Product Code: N.A. Pharmaceutical Form: Nasal spray, solution Pharmaceutical form of the placebo: Nasal spray, solution Route of administration of the placebo: Intranasal use (Noncurrent) CONDITION: Autism Spectrum Disorder ; MedDRA version: 20.0 Level: LLT Classification code 10003805 Term: Autism System Organ Class: 100000004873 Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: Main Objective: To evaluate the safety, the tolerability and the activity on social cognition of acute treatment of a single administration of IN‐OXT versus placebo. Primary end point(s): Safety and tolerability of IN‐OXT in young adults with ASD. Secondary Objective: To evaluate the activity of acute treatment of a single administration of IN‐OXT versus placebo on social cognition, repetitive behaviour and anxiety in ASD. Timepoint(s) of evaluation of this end point: About one month for each patient. SECONDARY OUTCOME: Secondary end point(s): Differences between IN‐OXT and placebo condition (between 0 and max 80 minutes since the IN‐OXT / placebo administration ) on direct observation of repetitive behaviors. Timepoint(s) of evaluation of this end point: About one month for each patient. INCLUSION CRITERIA: 1. Diagnosis of Autism Spectrum Disorder. 2. Participants aged 18‐45 years of age inclusive. 3. Gender: male. 4. IQ = 70 as measured with the WAIS‐IV. 5. Signed consent. 6. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in Italian. 7. Participant must be on a currently stable pharmacologic and/or psychoeducational treatments for at least 3 months and must not have made any treatment changes in the one month period prior to beginning this study. 8. Normality or not clinically significant abnormality identified on the medical or laboratory evaluation at the screening visit. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures. 9. Normality or not clinically significant abnormality vital P