Empathy, Autism and Oxytocin – an investigation by means of functional magnetic resonance imaging and moleculargenetic analyses

Phase 1

• Conditions: high-functioning autism spectrum disorders: autistic disorder (F84.0), Asperger syndrome (F84.5), atypical autism (F 84.1); MedDRA version: 17.1Level: LLTClassification code 10021737Term: Infantile autismSystem Organ Class: 100000004852; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-003750-89-DE
• Lead Sponsor: Philipps-University Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-21
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 72

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified