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Pacebo-controlled, double-blind, randomised phase II study with crossover-design investigating the modulatory effects of intranasal Oxytocin on social cognition in patients with Autism-Spectrum-Disorder

Pacebo-controlled, double-blind, randomised phase II study with crossover-design investigating the modulatory effects of intranasal Oxytocin on social cognition in patients with Autism-Spectrum-Disorder - Social Cognition-Autism-Oxytocin

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010053
Enrollment
200
Registered
2016-04-08
Start date
2017-02-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F84.0 F84.5 F84.1

Interventions

Group 1: Patients with Autism-Spectrum-Disorder and healthy controls: Oxytocin-Spray (Syntocinon): singular intranasal administration of 24 IU Time between intranasal administration: approx. 14 days

Sponsors

Max-Planck-Institut für Kognitions- und Neurowissenschaften
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
19 Years to 40 Years

Inclusion criteria

Inclusion criteria: Key inclusion criteria: ASD patients: Diagnosis of the three autistic disorders (according to ICD-10): F84.0, F84.5 F84.1, male, age 19 = age = 40 Healthy controls: Frequency matched with regard to age, IQ, and sex without diagnosis of ASD

Exclusion criteria

Exclusion criteria: Key exclusion criteria: IQ < 70; contraindications for OXT administration (e.g. known hypersensitivity to nasal sprays or other drugs); contraindications for the MRI assessment (e.g. incorporated metal, claustrophobia); comorbid drug, alcohol or nicotine abuse or dependence

Design outcomes

Primary

MeasureTime frame
The characterization of acute oxytocin effects on neural network activation in patients with autism-spectrum-disorder and healthy controls in regard on socio-affective and cognitive processes. Neural network activation will be measured with functional magnetic resonance imaging, once after oxytocin and once after placebo administration. The neural activation patterns and the behavior that are measured after the different nasal spray application will then be compared.

Secondary

MeasureTime frame
The influence of oxytocin on (a) reaction time and empatic judgments (b) pupillary dilation (c) eye fixations and the relationship of oxytocin outcomes to personality questionnaires. Reactions on empathic judgments will be made by each participant during the fMRI measurements, pupillary dilation and eye fixations will be measured with an eye-tracker while the fMRI measurements are taking place. The personality questionnaires will be filled in prior to the nasal spray application and may serve as an indicator on how differential oxytocin effects can be when particular traits are present in an individual.

Countries

Germany

Contacts

Public ContactKatrin Preckel

Max-Planck-Institut für Kognitions- und Neurowissenschaften

preckel@cbs.mpg.de+49 341 9940-2653

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 9, 2026