Healthy VolunteersSerogenNCT01644071
Serotonergic System and Violent Video Games
A study testing cipralex in people with Healthy Volunteers, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Aggressive behavior (AB) is a major burden to society with severe socio-economic consequences. Genetic studies suggest a high heritability of AB; in particular, the low expressing allele of the MAOA gene (MAOA-L) has been associated with increased AB. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- cipralex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Jun 2014
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- age 18-60 (adults), age 12-17 (juveniles)
- right-handedness
- German native language
Who cannot join
- any contraindications against MR investigations
- any contraindications against application of SSRIs
- any history of neurological or psychiatric illness
- history of drug abuse
- history of psychopharmacological therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital Aachen
Aachen, 52074
About this study
Official title: Genetic-pharmacological Neuroimaging of the Serotonergic System in Violent Video Games
Aggressive behavior (AB) is a major burden to society with severe socio-economic consequences. Genetic studies suggest a high heritability of AB; in particular, the low expressing allele of the MAOA gene (MAOA-L) has been associated with increased AB. Recent neural aggression models have suggested a dysfunctional emotion regulation circuit including amygdala, orbitofrontal, and anterior cingulate cortex. Dysregulated serotonergic (5-HT) projections from the anterior cingulate cortex to the amygdala have been suggested to promote aggressive behavior. This finding is well in line with the observation that the MAOA-L allele leads to a reduced expression of monoamine oxidase A and thus to an overflow of 5-HT in serotonergic cortico-amygdalar projections. However, due to methodological and ethical constraints, the neural substrates of AB are difficult to assess. A possible solution is the use of virtual violence which permits AB against virtual characters without direct consequences for any real person and can be easily applied in functional imaging experiments. There is evidence that virtual and real aggression share common neural substrates. AB in violent video games inhibits rostral anterior cingulate cortex (ACC) and amygdala in line with the suggested neurophysiological circuits underlying real-life AB.
Read the detailed description
Our study plan comprises the assessment of brain activation patterns during virtual AB in a violent video game with functional magnetic resonance imaging under three experimental conditions in randomized, double-blind fashion:
- Increase of synaptic 5-HT with a selective serotonin reuptake inhibitor (SSRI, Cipralex ®);
- reduction of synaptic 5-HT with the Rapid Tryptophan Depletion Test (RTD); and 3) Placebo.
A blood sample genotyping will assess the allelic expression of the MAOA gene. We hypothesize
- a modification of the ACC-amygdala system by the serotonergic intervention and
- an interaction with the genotype concerning the MAOA gene. The results of this study will give valuable insights into the neurogenetic biology underlying aggression which will open new perspectives for therapeutical and pharmacological intervention.
- Conditions
- Healthy Volunteers
- Being tested
- cipralex
- Keywords
- violent video games, serotonergic system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cipralexDrug
one time 10 mg, tablet
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Experimental | application of three treatments and three masurements within 3 weeks Receives: Drug: cipralex |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional neuroimaging
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 posted18 Jul 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644071
- Sponsor's protocol ID
- CTC-A_12-023
- Acronym
- Serogen
- Status last verified
- Sep 2015
- First submitted
- 20 Jun 2012
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic-pharmacological Neuroimaging of the Serotonergic System in Violent Video Games
- ClinicalTrials.gov ID
- NCT01644071
- Acronym / sponsor ID
- Serogen / CTC-A_12-023
- Conditions
- Healthy Volunteers
- Keywords
- violent video games, serotonergic system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Jul 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.
Aggressive behavior (AB) is a major burden to society with severe socio-economic consequences. Genetic studies suggest a high heritability of AB; in particular, the low expressing allele of the MAOA gene (MAOA-L) has been associated with increased AB. Recent neural aggression models have suggested a dysfunctional emotion regulation circuit including amygdala, orbitofrontal, and anterior cingulate cortex. Dysregulated serotonergic (5-HT) projections from the anterior cingulate cortex to the amygdala have been suggested to promote aggressive behavior. This finding is well in line with the observation that the MAOA-L allele leads to a reduced expression of monoamine oxidase A and thus to an overflow of 5-HT in serotonergic cortico-amygdalar projections. However, due to methodological and ethical constraints, the neural substrates of AB are difficult to assess. A possible solution is the use of virtual violence which permits AB against virtual characters without direct consequences for any real person and can be easily applied in functional imaging experiments. There is evidence that virtual and real aggression share common neural substrates. AB in violent video games inhibits rostral anterior cingulate cortex (ACC) and amygdala in line with the suggested neurophysiological circuits underlying real-life AB.
Detailed description
Our study plan comprises the assessment of brain activation patterns during virtual AB in a violent video game with functional magnetic resonance imaging under three experimental conditions in randomized, double-blind fashion:
- Increase of synaptic 5-HT with a selective serotonin reuptake inhibitor (SSRI, Cipralex ®);
- reduction of synaptic 5-HT with the Rapid Tryptophan Depletion Test (RTD); and 3) Placebo.
A blood sample genotyping will assess the allelic expression of the MAOA gene. We hypothesize
- a modification of the ACC-amygdala system by the serotonergic intervention and
- an interaction with the genotype concerning the MAOA gene. The results of this study will give valuable insights into the neurogenetic biology underlying aggression which will open new perspectives for therapeutical and pharmacological intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Drug: cipralexapplication of three treatments and three masurements within 3 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male
- age 18-60 (adults), age 12-17 (juveniles)
- right-handedness
- German native language
Key exclusion criteria (5 listed)
- any contraindications against MR investigations
- any contraindications against application of SSRIs
- any history of neurological or psychiatric illness
- history of drug abuse
- history of psychopharmacological therapy
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 |
|---|---|---|
| cipralexone time 10 mg, tablet | Drug | arm 1 |
Primary outcome
functional neuroimaging
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 29 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cipralex in people with Healthy Volunteers, 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 4 inclusion and 5 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 29 Sep 2015. 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?
functional neuroimaging (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 29 Sep 2015; AzTrials last refreshed its copy on 30 Oct 2026.