NCT02156661

Brief Summary

The purpose of this study is to determine whether oxytocin influences emotional processing and learning of emotional and social stimuli.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

June 3, 2014

Last Update Submit

May 5, 2017

Conditions

Healthy Males

Outcome Measures

Primary Outcomes (1)

  • Brain activity

    fMRI

    During emotion processing

Secondary Outcomes (1)

  • Psychophysiological response

    During stimuli presentation

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

Oxytocin: Syntocinon-Spray, Novartis intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Placebo nasal spray

Drug: Oxytocin

Interventions

OxytocinDRUG
OxytocinPlacebo

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 5, 2014

Study Start

May 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 9, 2017

Record last verified: 2017-05