Modulation of Reinforcement Learning

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01712464
First received: October 15, 2012
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Impact of Oxytocin on Social Learning
Drug: Oxytocin vs. Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Modulation of Reinforcement Learning and Neuronal Activation in Ventral Stratum by Oxytocin - a Pilot Study at Autism Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Bold Signal in nucleus accumbens [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    during social learning at one treatment with oxytocin vs placebo


Secondary Outcome Measures:
  • Bold signal in ventral tegmental areal [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    during social learning at one treatment with oxytocin vs placebo


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 and 25 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712464

Contacts
Contact: Martin Schulte-Rühter, Dr. rer. nat. +49 241 80 89892 mschulte@ukaachen.de

Locations
Germany
Universtiy Hospital Aachen Recruiting
Aachen, Northrhine-Westfalia, Germany, 52074
Contact: Martin Schulte-Rüther, Dr. rer. nat.    +49 241 80 89892    mschulte@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Investigators
Study Director: Martin Schulte-Rüther, Dr. rer. nat University Hospital, Aachen
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01712464     History of Changes
Other Study ID Numbers: 12-033
Study First Received: October 15, 2012
Last Updated: May 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014