Neural Correlates of Empathogenic and Affiliative Actions of Oxytocin (ODIS)
This study is currently recruiting participants.
Verified October 2012 by University Hospital, Bonn
Sponsor:
University Hospital, Bonn
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01701180
First received: October 2, 2012
Last updated: October 3, 2012
Last verified: October 2012
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Purpose
Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin has prosocial effects. However, the neural substrates of these effects are still unclear. The investigators hypothesized that a single dose administration of oxytocin should increase empathogenic and affiliative responses and that these effects are mediated by an increased insula activity.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Oxytocin Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Neural Correlates of the Empathogenic and Affiliative Actions of Oxytocin |
Resource links provided by NLM:
Further study details as provided by University Hospital, Bonn:
Primary Outcome Measures:
- Empathy ratings and their neural correlates [ Time Frame: About one hour after the intranasal administration of oxytocin ] [ Designated as safety issue: No ]All subjects are scanned while they view emotional and neutral faces and rate their empathy for these stimuli.
Secondary Outcome Measures:
- Neural correlates of pair-bonding [ Time Frame: About one hour after the intranasal administration of oxytocin ] [ Designated as safety issue: No ]All subjects are scanned while they view a picture of their mate and and an unknown female.
| Estimated Enrollment: | 35 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Oxytocin
24 IU Oxytocin, intranasal application 45 min prior to the experiment
|
Drug: Oxytocin
24 IU; 3 puffs per nostril, each with 4 IU OXT
Other Name: Oxytocin: Syntocinon-Spray, Novartis
|
|
Placebo Comparator: Placebo
Intranasal application, sodium chloride solution, 3 puffs per nostril
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male volunteers
- In a heterosexual relationship
Exclusion Criteria:
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701180
Contacts
| Contact: René Hurlemann, MD PhD M.Sc. | +49 (0)228 287 15057 | renehurlemann@me.com |
| Contact: Dirk Scheele, M.Sc. | +49 (0)228 287 11151 | Dirk.Scheele@ukb.uni-bonn.de |
Locations
| Germany | |
| Department of Psychiatry, University of Bonn | Recruiting |
| Bonn, North Rhine-Westphalia, Germany, 53105 | |
| Contact: René Hurlemann, MD PhD M.Sc. +49 (0)228 287 15057 renehurlemann@me.com | |
| Contact: Dirk Scheele, M.Sc. +49 (0)228 287 11151 Dirk.Scheele@ukb.uni-bonn.de | |
| Sub-Investigator: Dirk Scheele, M.Sc. | |
Sponsors and Collaborators
University Hospital, Bonn
Investigators
| Principal Investigator: | René Hurlemann, MD PhD M.Sc. | Department of Psychiatry University of Bonn |
More Information
Additional Information:
No publications provided
| Responsible Party: | Rene Hurlemann, MSc MD PhD, University Hospital, Bonn |
| ClinicalTrials.gov Identifier: | NCT01701180 History of Changes |
| Other Study ID Numbers: | OXT-151/12, OXT-151/12 |
| Study First Received: | October 2, 2012 |
| Last Updated: | October 3, 2012 |
| Health Authority: | Germany: Ethics Board, University of Bonn |
Keywords provided by University Hospital, Bonn:
|
Male Volunteers |
Additional relevant MeSH terms:
|
Oxytocin Oxytocics Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013