NCT02501837

Brief Summary

The neuropeptide oxytocin (OXT) has been identified as a key modulator of human social behavior and it has been recently shown that OXT also contributes to pair-bonding in men. However, it is still elusive whether OXT has similar effects in women. In the present study, the investigators examine the effect of intranasal OXT on behavioral ratings of and neural responses to the male partner in female participants. In a second experiment, the modulatory effect of OXT on emotion regulation is investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1 healthy

Timeline
Completed

Started Jul 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

July 15, 2015

Last Update Submit

July 15, 2015

Conditions

Keywords

Healthy women

Outcome Measures

Primary Outcomes (2)

  • Neural response to photographs of the partner

    Neural responses will be measured by using functional magnetic resonance imaging (fMRI). In the fMRI analysis the effect of oxytocin on the neural response to the photograph of the partner will be compared with placebo.

    About one hour after the intranasal administration of oxytocin

  • Neural response during the regulation of food craving

    Neural responses will be measured by using functional magnetic resonance imaging (fMRI). In the fMRI analysis the effect of oxytocin on the neural response to the regulation of food craving will be compared with placebo.

    About one hour after the intranasal administration of oxytocin

Secondary Outcomes (3)

  • Attractiveness ratings of all stimuli

    About one hour after the intranasal administration of oxytocin

  • Arousal ratings of all stimuli

    About one hour after the intranasal administration of oxytocin

  • Food craving ratings

    About one hour after the intranasal administration of oxytocin

Study Arms (2)

Oxytocin

EXPERIMENTAL

24 IU Oxytocin (Syntocinon spray), intranasal application 30 min prior to the experiment

Drug: Syntocinon-Spray

Placebo

PLACEBO COMPARATOR

Intranasal application, containing all ingredients except for the peptide, 3 puffs per nostril

Drug: Syntocinon-Spray

Interventions

Intranasal administration of 24 IU Oxytocin

OxytocinPlacebo

Eligibility Criteria

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

You may qualify if:

  • Healthy female volunteers
  • In a heterosexual relationship

You may not qualify if:

  • Current or past psychiatric disease
  • Current or past physical illness
  • Psychoactive medication
  • Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University of Bonn

Bonn, 53105, Germany

Location

Related Links

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
Antragsteller und verantwortlicher Leiter

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 17, 2015

Study Start

July 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations