Oxytocin and Resting State fMRI

February 18, 2016 updated by: Monika Eckstein, University Hospital Heidelberg

Intranasal Oxytocin and Resting State fMRI in Healthy Volunteers

The goal of the study is to investigate the effects of intranasal oxytocin (OT) or placebo to resting state brain activity in healthy males.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although several fMRI studies investigated the neural correlates of OT administration, only few have focused on the underlying modulatory effects of OT on baseline brain function. While functional MRI examines the neural activity during a certain task, it might be especially interesting to assess the main effect of OT on the basic activity of the human brain in rest. This resting state activity becomes typically evident in the default mode network (DMN), compromising midline structures such as medial frontal cortex, cingulate and precuneus, as well as specific resting state networks .

In fact, a recent study succeeded in demonstrating a modulatory influence of OT. Recent studies were able to show an increased functional connectivity at rest of amygdala to the medial prefrontal cortex (PFC) in a small sample of 15 subjects.

However, distinct subregions of the amygdala seem to be involved in different OT effects. To goal of the present study is to decipher the modulatory effects of OT to subregions of the amygdala in a larger sample using improved anatomical mapping of the seed regions and relate these alterations to individual traits of healthy volunteers. We expected to add evidence to the increase of amygdala - PFC connectivity under OT as well as detailed anatomical mapping of this networks.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Health

Exclusion Criteria:

  • Chronic physical or mental illness, regular smoking or alcohol consumption and medication intake

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Active Comparator: OT
Oxytocin
Drug: Oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resting state brain activity using fMRI
Time Frame: 30min
30min

Secondary Outcome Measures

Outcome Measure
Time Frame
Subject personality using questionnaires
Time Frame: 30min
30min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OT-REST14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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