Endophenotyping With Functional Magnetic Resonance Imaging (fMRI)
NGFN PLUS TP13
Endophenotyping With fMRI: Genetic Modulation and Treatment Response
1 other identifier
observational
480
1 country
1
Brief Summary
The mesolimbic dopaminergic reward system is a key structure underlying addictive behaviour in alcohol addiction and is under control of prefrontal glutamatergic neurotransmission. The aim of the present multicenter-study in Berlin, Bonn and Mannheim is to use functional magnetic resonance imaging (fMRI) in alcohol addiction for endophenotyping in order to study the relevance of genetic variation, in particular in dopaminergic and glutamatergic genes, for addiction. The investigators will use a temporal discounting and a cue reactivity paradigm in alcoholics and healthy controls in order to 1) test the impact of genetic variation on activation of the mesolimbic system in these populations and to 2) to test their predictive effects for treatment outcome in alcoholics. The subproject will thus bridge animal research on genetically determined cue reactivity and human studies in alcoholics. Furthermore, the investigators will link these results to the measurement of glutamate and glutamine with magnetic resonance spectroscopy (MRS) in subproject SP14.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 2, 2012
CompletedFirst Posted
Study publicly available on registry
January 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJanuary 28, 2016
January 1, 2016
4.7 years
January 2, 2012
January 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
blood oxygenation level dependent (BOLD) response
investigation of neuronal activation of the mesolimbic system in alcohol-dependent patients and healthy controls using 3 tesla magnetic resonance imaging
first assessment timepoint (alc.dep. patients: up to 21 days after detoxification)
Genetic endophenotypes
study the relevance of genetic variation, in particular in dopaminergic and glutamatergic genes, for addiction
second assessment timepoint: 3 days after first assessment time point
Secondary Outcomes (1)
Treatment response
6 month follow up period beginning after second assessment timepoint
Study Arms (2)
Alcohol-dependent patients
* men and women, aged 18 to 75 * legally effective, written informed consent for participation within the study * right handedness * no other psychiatric disorder according to ICD 10 * no psychotropic substances within the last 7 days
Healthy control subjects
* men and women, aged 18 to 75 * legally effective, written informed consent for participation within the study * right handedness * no psychiatric disorder according to ICD 10 * no psychotropic substances within the last 7 days
Eligibility Criteria
primary care clinic
You may qualify if:
- Healthy Controls
- men and women, aged 18 to 75
- legally effective, written informed consent for participation within the study
- right handedness
- no psychiatric disorder according to ICD 10
- no psychotropic substances within the last 7 days Alcohol-dependent patients
- men and women, aged 18 to 75
- legally effective, written informed consent for participation within the study
- right handedness
- no other psychiatric disorder according to ICD 10
- no psychotropic substances within the last 7 days
You may not qualify if:
- physical disorders, which might interfere with the planned examination (e.g. cerebral or organic disorder)
- MR-contraindication (z.B. pace maker, metalic or electronic implants, metal splinters, operation clips)
- anamnestic manifest psychiatric axis I disorder and/or axis II according to ICD-10 except alcohol dependence for patients
- medication or drug dependence
- medication or drug abuse (randomized urin testing)
- insufficient knowledge of German language
- claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charite University, Berlin, Germanylead
- Central Institute of Mental Health, Mannheimcollaborator
- University Hospital, Bonncollaborator
Study Sites (1)
Dept. of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117, Germany
Related Publications (1)
Jorde A, Bach P, Witt SH, Becker K, Reinhard I, Vollstadt-Klein S, Kirsch M, Hermann D, Charlet K, Beck A, Wimmer L, Frank J, Treutlein J, Spanagel R, Mann K, Walter H, Heinz A, Rietschel M, Kiefer F. Genetic variation in the atrial natriuretic peptide transcription factor GATA4 modulates amygdala responsiveness in alcohol dependence. Biol Psychiatry. 2014 May 15;75(10):790-7. doi: 10.1016/j.biopsych.2013.10.020. Epub 2013 Nov 4.
PMID: 24314346DERIVED
Related Links
Biospecimen
whole blood (EDTA)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Heinz, MD
Charite University, Berlin, Germany
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
January 2, 2012
First Posted
January 4, 2012
Study Start
June 1, 2008
Primary Completion
February 1, 2013
Study Completion
June 1, 2013
Last Updated
January 28, 2016
Record last verified: 2016-01