NCT02350946

Brief Summary

The purpose of this study is to shed light on the basic neurobiological mechanisms which underlie social information processing in healthy men. More specifically, we intend to examine whether a person's social competence level is related to the patterns of neural activity and his visual search strategies during evaluation of social scenes. Furthermore, it will be assessed whether an oxytocin-driven increase in activity in brain areas relevant to the task will facilitate social information processing and thus enhance task performance. Additionally it will be examined whether oxytocin can facilitate response inhibition in an emotional context.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

January 20, 2015

Last Update Submit

January 26, 2015

Conditions

The Impact of Oxytocin on Social Cognition

Outcome Measures

Primary Outcomes (2)

  • BOLD response during emotion recognition in contrast with a corresponding control condition.

    In the Social Detection Task, subjects' brain activity when viewing social scenes will be compared to corresponding control scenes in which no people are shown. In the GoNoGo Task several emotional conditions will be compared to a neutral control condition.

    (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])

  • BOLD response during response inhibition (Emotional Go/ Nogo) in contrast with a corresponding control condition.

    Brain activation during NoGo trials will be compared to brain activation during Go trials from the same emotional condition.

    (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])

Secondary Outcomes (7)

  • Serum levels of Oxytocin

    (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])

  • Serum levels of Prolaktin

    (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])

  • Serum levels of Cortisol

    (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])

  • Total length of fixations on areas of interest (AOIs) assessed via eye-tracking

    (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])

  • Number of fixations on areas of interest (AOIs) assessed via eye-tracking

    (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])

  • +2 more secondary outcomes

Study Arms (2)

Cross over Oxytocin and Placebo

EXPERIMENTAL

fMRI measurement and blood examinations following 26 IU Oxytocin (Syntocinon) on day 1 and following placebo on day 14

Drug: OxytocinDrug: Placebo

Cross over Placebo and Oxytocin

EXPERIMENTAL

fMRI measurement and blood examinations following placebo on day 1 and following 26 IU Oxytocin (Syntocinon) on day 14

Drug: OxytocinDrug: Placebo

Interventions

OxytocinDRUG
Cross over Oxytocin and PlaceboCross over Placebo and Oxytocin
PlaceboDRUG
Cross over Oxytocin and PlaceboCross over Placebo and Oxytocin

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • MRI- eligibility
  • Subject's ability to fully grasp the type, scope and individual consequences of the study
  • Willingness to participate in and comply with the study procedures as indicated by signing the dated informed consent form

You may not qualify if:

  • Left-handedness
  • Smoking
  • Regular intake of medication
  • Hypersensitivity towards oxytocin or a chemically similar substance
  • Current or previous neurological or psychiatric disorder
  • Nose surgery or chronic sinus infection
  • Any somatic disorder that may interfere with the experimental procedures, affect the outcome measures or pose a risk for the participant during performance of the experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital RWTH Aachen

Aachen, Germany

RECRUITING

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Lisa Deuse

CONTACT

02418085692ldeuse@ukaachen.de

Sarah E Groppe

CONTACT

02418037151sgroppe@ukaachen.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 30, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

DE(1)