Impact of Oxytocin on Social LearningNCT01712464
Modulation of Reinforcement Learning
A study of Impact of Oxytocin on Social Learning, run by RWTH Aachen University at 1 site in Germany.
Trial summary
This study aims to examine the modulation of neuronal and behavioural parameters of social reinforcement learning. Read more about this study
- Who is it for?
- Ages 18 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Impact of Oxytocin on Social Learning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 18 Oct 2013to 7 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Impact of Oxytocin on Social Learning
- Being tested
- Oxytocin vs. Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin vs. PlaceboDrug
FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Cross over Oxytocin and Placebo | Other | FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days Receives: Drug: Oxytocin vs. Placebo |
| Cross over Placebo and Oxytocin | Other | FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days Receives: Drug: Oxytocin vs. Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bold Signal in nucleus accumbens
during social learning at one treatment with oxytocin vs placebo
Measured: 1 Day
Secondary outcomes (1)
Bold signal in ventral tegmental areal
during social learning at one treatment with oxytocin vs placebo
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study start18 Oct 2013
- Primary completion7 Aug 2016
- Study completion7 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Oxytocin on Social LearningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Schulte-Rüther, Dr. rer. nat, Study director, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712464
- Sponsor's protocol ID
- 12-033
- Status last verified
- Apr 2018
- First submitted
- 15 Oct 2012
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Reinforcement Learning and Neuronal Activation in Ventral Stratum by Oxytocin - a Pilot Study at Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01712464
- Acronym / sponsor ID
- 12-033
- Conditions
- Impact of Oxytocin on Social Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 18 Oct 2013 (actual)
- Primary completion
- 7 Aug 2016 (actual)
- Study completion
- 7 Aug 2016 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine the modulation of neuronal and behavioural parameters of social reinforcement learning.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross over Oxytocin and Placebo | Other | Drug: Oxytocin vs. PlaceboFMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days |
| Cross over Placebo and Oxytocin | Other | Drug: Oxytocin vs. PlaceboFMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 and 26 years
- male
- IQ>80
- written informed consent
- proband understands character, extent and individual consequences of the study
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin vs. PlaceboFMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days | Drug | Cross over Oxytocin and Placebo, Cross over Placebo and Oxytocin |
Primary outcome
Bold Signal in nucleus accumbens
Time frame: 1 Day
during social learning at one treatment with oxytocin vs placebo
1 secondary outcome
Bold signal in ventral tegmental areal
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Schulte-Rüther, Dr. rer. nat study director
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Impact of Oxytocin on Social Learning, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bold Signal in nucleus accumbens (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.