NCT01701180

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for early_phase_1 healthy

Timeline
Completed

Started Aug 2012

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

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

October 2, 2012

Last Update Submit

December 2, 2014

Conditions

Healthy

Keywords

Male Volunteers

Outcome Measures

Primary Outcomes (1)

  • Empathy ratings and their neural correlates

    All subjects are scanned while they view emotional and neutral faces and rate their empathy for these stimuli.

    About one hour after the intranasal administration of oxytocin

Secondary Outcomes (1)

  • Neural correlates of pair-bonding

    About one hour after the intranasal administration of oxytocin

Study Arms (2)

Oxytocin

EXPERIMENTAL

24 IU Oxytocin, intranasal application 45 min prior to the experiment

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Intranasal application, sodium chloride solution, 3 puffs per nostril

Drug: Placebo

Interventions

OxytocinDRUG

24 IU; 3 puffs per nostril, each with 4 IU OXT

Also known as: Oxytocin: Syntocinon-Spray, Novartis
Oxytocin
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy male volunteers
  • In a heterosexual relationship

You may not qualify if:

  • Current or past psychiatric disease
  • Current or past physical illness
  • Psychoactive medication
  • Tobacco smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University of Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Related Links

MeSH Terms

Interventions

Oxytocinlactitol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • René Hurlemann, MD PhD M.Sc.

    Department of Psychiatry University of Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc MD PhD

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 4, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

DE(1)