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OpenTrials
Completed

NCT Number: NCT01712464

Modulation of Reinforcement Learning

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

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Key information

Conditions

Impact of Oxytocin on Social Learning

Age range

18 year–26 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universtiy Hospital Aachen

Aachen, Northrhine-Westfalia, 52074, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin vs. Placebo

Drug

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

Primary outcomes

  1. Bold Signal in nucleus accumbens

    Time frame: 1 Day

    during social learning at one treatment with oxytocin vs placebo

Secondary outcomes

  1. Bold signal in ventral tegmental areal

    Time frame: 1 Day

    during social learning at one treatment with oxytocin vs placebo

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2012
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.