Modulation of Reinforcement Learning

Not Applicable

Completed

• Conditions: Impact of Oxytocin on Social Learning
• Interventions: Drug: Oxytocin vs. Placebo

• Registration Number: NCT01712464
• Lead Sponsor: RWTH Aachen University

Brief Summary

This study aims to examine the modulation of neuronal and behavioural parameters of social reinforcement learning.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-19
• Study First Posted: 2012-10-23
• Study Start: 2013-10-18
• Primary Completion: 2016-08-07
• Study Completion: 2016-08-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Age between 18 and 26 years
• male
• IQ>80
• written informed consent
• proband understands character, extent and individual consequences of the study
• competent persons who are able to follow the instructions of the study personnel
• for ASD patients: assured ASD diagnosis, comply of the ASD criteria ADI-R/ADOS-G

Exclusion Criteria

• prosopagnosia
• anaphylaxis of oxytocin or other chemical substances
• metal inside the body or other contraindications of mri scan
• physical illness which can affect the examinations or endanger the proband
• actual or assumed drug or alcohol abuse
• persons who are accommodated in an institution because of court or administrative order
• persons with a relationship of dependence to the sponsor or investigator
• healthy probands: psychiatric disorder according to ICD-10-WHO F at the moment and in history, continuous drug-intake at time of measurements
• patients with ASD: psychiatric disorder according to ICD-10-WHO F (except ASD disorder in patient group) during the last 12 month being not treated, continuous drug-intake at time of measurements (psychotropic medication), exception: stimulants used for treatment of attention disorders, if they can come off for the measurements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cross over Placebo and Oxytocin	Oxytocin vs. Placebo	FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
Cross over Oxytocin and Placebo	Oxytocin vs. Placebo	FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days

Primary Outcome Measures

Name	Time	Method
Bold Signal in nucleus accumbens	1 Day	during social learning at one treatment with oxytocin vs placebo

Secondary Outcome Measures

Name	Time	Method
Bold signal in ventral tegmental areal	1 Day	during social learning at one treatment with oxytocin vs placebo

Trial Locations

Locations (1)

Universtiy Hospital Aachen; 🇩🇪 Aachen, Northrhine-Westfalia, Germany