Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2013-10-18
2016-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Study Groups
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Cross over Oxytocin and Placebo
FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
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
Oxytocin vs. Placebo
FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
Interventions
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Oxytocin vs. Placebo
FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
26 Years
MALE
Yes
Sponsors
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RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Martin Schulte-Rüther, Dr. rer. nat
Role: STUDY_DIRECTOR
University Hospital, Aachen
Locations
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Universtiy Hospital Aachen
Aachen, Northrhine-Westfalia, Germany
Countries
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Other Identifiers
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12-033
Identifier Type: -
Identifier Source: org_study_id
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