Modulation of Reinforcement Learning

Modulation of Reinforcement Learning and Neuronal Activation in Ventral Stratum by Oxytocin - a Pilot Study at Autism Spectrum Disorder

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

Study Overview

• Status: Completed
• Conditions: Impact of Oxytocin on Social Learning
• Intervention / Treatment: Drug: Oxytocin vs. Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Northrhine-Westfalia
    • Aachen, Northrhine-Westfalia, Germany, 52074
      • Universtiy Hospital Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Cross over Oxytocin and Placebo; FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days	Drug: Oxytocin vs. Placebo; FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
OTHER: Cross over Placebo and Oxytocin; FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days	Drug: Oxytocin vs. Placebo; FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bold Signal in nucleus accumbens	during social learning at one treatment with oxytocin vs placebo	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bold signal in ventral tegmental areal	during social learning at one treatment with oxytocin vs placebo	1 Day

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Study Director: Martin Schulte-Rüther, Dr. rer. nat, University Hospital, Aachen

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2013
• Primary Completion (ACTUAL): August 7, 2016
• Study Completion (ACTUAL): August 7, 2016

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 19, 2012
• First Posted (ESTIMATE): October 23, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 12-033