NCT01644071

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

2 years

First QC Date

June 20, 2012

Last Update Submit

September 28, 2015

Conditions

Keywords

violent video gamesserotonergic system

Outcome Measures

Primary Outcomes (1)

  • functional neuroimaging

    1 day

Study Arms (1)

arm 1

EXPERIMENTAL

application of three treatments and three masurements within 3 weeks

Drug: cipralex

Interventions

one time 10 mg, tablet

arm 1

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • age 18-60 (adults), age 12-17 (juveniles)
  • right-handedness
  • German native language

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital Aachen

Aachen, 52074, Germany

Location

MeSH Terms

Interventions

Dexetimide

Intervention Hierarchy (Ancestors)

PiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2012

First Posted

July 18, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2014

Study Completion

June 1, 2014

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations