high-functioning autism spectrum disorders: autistic disorder (F84.0), Asperger syndrome (F84.5), atypical autism (F 84.1) MedDRA version: 17.1 Level: LLT Classification code 10021737 Term: Infantile autism System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Syntocinon® spray
Product Name: Oxytocin nasal spray (Syntocinon® spray)
Pharmaceutical Form: Nasal spray
INN or Proposed INN: oxytocin
CAS Number: 50-56-6
Other descriptive name: OXYTOCIN
Sponsors
Philipps-University Marburg
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Diagnosis of autistic disorder (F84.0 according to ICD-10), Asperger syndrome (F84.5 according to ICD-10), atypical autism (F84.1 according to ICD-10) Male patients Age 15 = years = 35 German as native language Right-handedness ( Edinburgh Inventory of Handedness; Oldfield, 1971) genotyped SNP rs53576 in the oxytocin receptor gene Signed form of consent (for underage persons: legal guardian) Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 49 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Female 18 = BMI = 30 IQ < 70 traumatic lesions of the brain serious neurologic diseases (e.g. epilepsy) incorporated metal acute suicidal tendency according to the clinical impression anamnestic known metabolic or endocrinologic disorders cardiac disorders (anamnesis, electrocardiogram, blood pressure and pulse): 50 = heart rate (bpm) = 90, 100 = blood pressure systolic (mmHg) = 140; 60 = blood pressure diastolic (mmHg) = 90 anamnestic known hypersensitivity to nasal sprays or other drugs comorbid drug, alcohol or nicotine (no more than 15 cigarettes per day) abuse or dependence within the 2 hours before the application of oxytocin/placebo intake of food, coffee, beverages (except water), nicotin-consumption as well as excessive fluid intake cold
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aim of the trial is to investigate if the intranasal applied Oxytocin (vs. Placebo) leads to an increased modulation of the neural network of empathy in patients with high-functioning autism dependent on the genotype of the SNP rs53576 in the oxytocin receptor gene.;Secondary Objective: 1. Influence of intranasal applied oxytocin on empathy in patients with high-functioning autism On the basis of recent publications it is expected, that intranasal applied Oxytocin leads to an attenuated activation of the amygdala and an increased activation of the neural network of empathy compared to placebo. 2. Influence of the genotypes of the SNP rs53576 in the oxytocin receptor gene on the activation of the neural network of empathy in patients with high-functioning autism. Intranasal applied oxytocin in carriers of the risk allele A of the SNP rs53576 in the OXTR (A/A and G/A) leads to an attenuated activation in the neural network of empathy [anterior insula, ACC (anterior cingulate cortex), amygdala, thalamus, PAG (periaqueductal gray), FG (fusiform gyrus)] during empathic processes. ;Primary end point(s): Activation of the neural network of empathy [anterior insula, ACC (anterior cingulate cortex), amygdala, thalamus, PAG (periaqueductal gray), FG (fusiform gyrus)] dependent on the oxytocin-/placebo-application and dependent on the genotype of the SNP rs53576 in the oxytocin receptor gene;Timepoint(s) of evaluation of this end point: during the 45. and 80. minute after verum/placebo application | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Ascertainment of variables of personality, values of psychopathology and subjective valuation during the task performance.;Timepoint(s) of evaluation of this end point: during the 45. and 80. minute after verum/placebo application | — |
Countries
Germany
Contacts
Public ContactKatarzyna Piskulak
Koordinierungszentrum für Klinische Studien der Philipps-Universität Marburg
Outcome results
None listed