A placebo-controlled, double blind, randomised trial with crossover-design investigating the effect of oxytocin nasal spray on neuronal processes of empathy

Phase 3

Recruiting

• Conditions: F84.0; F84.1; F84.5; Childhood autism; Atypical autism; Asperger syndrome

• Registration Number: DRKS00008984
• Lead Sponsor: Philipps-Universität Marburg vertreten durch das Koordinierungszentrum für Klinische Studien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

Diagnosis of childhood autism (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
- genotyped SNP rs53576 in the oxytocin receptor gene
- Signed form of consent (for underage persons: legal guardian)

Exclusion Criteria

- Female
- 18 = BMI = 30
- IQ < 70
- traumatic lesions of the brain
- serious neurologic diseases (e.g. epilepsy)
- metal implants
- acute suicidal tendency according to the clinical impression
- metabolic or endocrinologic disorders stated in the case history
- cardiovascular disorders (anamnesis, electrocardiogram, blood pressure and pulse): 50 = heart rate (bpm) = 90, 100 = blood pressure systolic (mmHg) = 140; 60 = blood pressure diastolic (mmHg) = 90
- hypersensitivity to nasal sprays or other drugs stated in the case history
- comorbid drug, alcohol or nicotine (no more than 15 cigarettes per day) abuse or addiction
- intake of food, coffee, beverages (except water), nicotin-consumption as well as excessive fluid intake within the 2 hours before the application of oxytocin/placebo
- common cold

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fMRI assessment of the activation of the neural network of empathy [anterior insula, ACC (anterior cingulate cortex), amygdala, thalamus, PAG (periaqueductal grey), FG (fusiform gyrus)] 45 minutes after intranasal application of oxytocin/placebo during processing of 3 paradigms (empathy for pain, sadness and embarassment). Assessment will be executed dependent on the oxytocin-/placebo application and on the genotype of the SNP rs53576 in the oxytocin receptor gene.

Secondary Outcome Measures

Name	Time	Method
Collection of data on variables of personality, psychopathology and subjective ratings during the task performance by questionnaires.