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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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2019-12-13
2021-05-31
Brief Summary
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Detailed Description
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To disentangle (sub)region-specific effects of OXT on task-related activations of the cingulate structures, the amygdala, the striatum, PAG and VMPFC, the investigators plan to acquire ultra-high field 7T fMRI data from healthy male participants while they perform (i) an emotional face matching task and (ii) a flight initiation distance (FID) task involving fast- or slow-attacking virtual predators that elicit distinct activations in the reactive and cognitive fear circuits. Furthermore, participants will be pre-stratified depending on RAGE polymorphisms to elucidate possible RAGE-related differential OXT effects.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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RAGE polymorphism (TT)
30 participants with the RAGE polymorphism (-374 T/A: rs1800624; TT) will be selected and scanned twice.
Oxytocin nasal spray
Intranasal administration of 24 International Units oxytocin 30 minutes before the start of the tasks.
Placebo
The placebo nasal sprays contain identical ingredients except for the peptide itself (30 minutes before the start of the tasks).
RAGE polymorphism (TA/AA)
30 participants with the RAGE polymorphism (-374 T/A: rs1800624; TA/AA) will be selected and scanned twice.
Oxytocin nasal spray
Intranasal administration of 24 International Units oxytocin 30 minutes before the start of the tasks.
Placebo
The placebo nasal sprays contain identical ingredients except for the peptide itself (30 minutes before the start of the tasks).
Interventions
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Oxytocin nasal spray
Intranasal administration of 24 International Units oxytocin 30 minutes before the start of the tasks.
Placebo
The placebo nasal sprays contain identical ingredients except for the peptide itself (30 minutes before the start of the tasks).
Eligibility Criteria
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Inclusion Criteria
* healthy male volunteers
* right handed
Exclusion Criteria
* current psychiatric medication or psychotherapy
* MRI contraindication (e.g. metal in body, claustrophobia)
18 Years
40 Years
MALE
Yes
Sponsors
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University Hospital, Bonn
OTHER
Responsible Party
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Rene Hurlemann
Professor for Psychiatry
Principal Investigators
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Rene Hurlemann, MSc, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oldenburg
Locations
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Department of Psychiatry and Medical Psychology
Bonn, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Hahn A, Kranz GS, Seidel EM, Sladky R, Kraus C, Kublbock M, Pfabigan DM, Hummer A, Grahl A, Ganger S, Windischberger C, Lamm C, Lanzenberger R. Comparing neural response to painful electrical stimulation with functional MRI at 3 and 7 T. Neuroimage. 2013 Nov 15;82:336-43. doi: 10.1016/j.neuroimage.2013.06.010. Epub 2013 Jun 12.
Hudson BI, Stickland MH, Futers TS, Grant PJ. Effects of novel polymorphisms in the RAGE gene on transcriptional regulation and their association with diabetic retinopathy. Diabetes. 2001 Jun;50(6):1505-11. doi: 10.2337/diabetes.50.6.1505.
Qi S, Hassabis D, Sun J, Guo F, Daw N, Mobbs D. How cognitive and reactive fear circuits optimize escape decisions in humans. Proc Natl Acad Sci U S A. 2018 Mar 20;115(12):3186-3191. doi: 10.1073/pnas.1712314115. Epub 2018 Mar 5.
Yamamoto Y, Liang M, Munesue S, Deguchi K, Harashima A, Furuhara K, Yuhi T, Zhong J, Akther S, Goto H, Eguchi Y, Kitao Y, Hori O, Shiraishi Y, Ozaki N, Shimizu Y, Kamide T, Yoshikawa A, Hayashi Y, Nakada M, Lopatina O, Gerasimenko M, Komleva Y, Malinovskaya N, Salmina AB, Asano M, Nishimori K, Shoelson SE, Yamamoto H, Higashida H. Vascular RAGE transports oxytocin into the brain to elicit its maternal bonding behaviour in mice. Commun Biol. 2019 Feb 25;2:76. doi: 10.1038/s42003-019-0325-6. eCollection 2019.
Hariri AR, Tessitore A, Mattay VS, Fera F, Weinberger DR. The amygdala response to emotional stimuli: a comparison of faces and scenes. Neuroimage. 2002 Sep;17(1):317-23. doi: 10.1006/nimg.2002.1179.
Related Links
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Neuromodulation of Emotion (NEMO) Research Group
Other Identifiers
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RAGE
Identifier Type: -
Identifier Source: org_study_id
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