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CompletedNCT01712464Updated May 1, 2018

Modulation of Reinforcement Learning

An interventional study of Oxytocin vs. Placebo in Impact of Oxytocin on Social Learning, sponsored by RWTH Aachen University. Completed at 1 site in Germany. Open to male participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by RWTH Aachen University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 26 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Impact of Oxytocin on Social Learning
03

In context

Lead sponsor

RWTH Aachen University is the lead sponsor of 230 studies on the registry; 19 are open to participants now.

Browse RWTH Aachen University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 26 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugOxytocin vs. Placebo

    FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days

06

What researchers measure

Primary outcomes

  1. Bold Signal in nucleus accumbens

    during social learning at one treatment with oxytocin vs placebo

    Time frame: 1 Day

Secondary outcomes

  1. Bold signal in ventral tegmental areal

    during social learning at one treatment with oxytocin vs placebo

    Time frame: 1 Day

07

Study locations

1 site
  • Universtiy Hospital Aachen
    Aachen, Northrhine-Westfalia 52074, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01712464
Lead sponsor
RWTH Aachen University
Responsible party
Sponsor
First posted
Oct 23, 2012
Start date
Oct 18, 2013
Primary completion
Aug 7, 2016
Completion
Aug 7, 2016
Last update
May 1, 2018

Study contacts

Martin Schulte-Rüther, Dr. rer. nat
study director · University Hospital, Aachen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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