Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety

October 26, 2018 updated by: Keith Kendrick, University of Electronic Science and Technology of China
To examine whether multiple doses of oxytocin have different effects on behavior and neural indices in males with high or low trait anxiety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the present study, healthy male subjects' trait anxiety levels will be assessed by the sub-trait inventory of the State-Trait Anxiety Inventory (STAI). According to subjects' trait anxiety scores, they will be divided into high or low anxiety experimental groups.

Next, experiments will investigate the acute effect (single dose) and chronic effect (3 doses or 5 doses) of oxytocin on brain functional connectivity during resting-state and brain activation in response to watching emotional stimuli using functional magnetic resonance imaging (fMRI). Also the brain structure data (T1 and diffusion tensor imaging, DTI) of subjects will be collected. After finishing the scanning tasks, subjects will be required to rate the emotional valence, intensity and arousal of the pictures shown in the scanner.

During the course of the study subjects will complete a number of questionnaires: Empathy Quotient (EQ), Cheek and Buss Shyness scale (CBSS),Interpersonal Reactivity Index (IRI),Childhood Trauma Questionnaire (CTQ),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS),Positive and Negative Affect Schedule (PANAS),d2 attention test, and the Visual Analogue Scale for anxiety.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610054
        • School of Life science and Technology, University of Electronic Science and Technology of China

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 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion:

  • healthy adult males

Exclusion:

  • past or current psychiatric or neurological disorder
  • head trauma
  • substance abuse
  • medication
  • fMRI contraindications (e.g. metal implants)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High anxiety group (single dose)
Oxytocin nasal spray or placebo nasal of one dose in subjects with high trait anxiety.
Drug: Oxytocin nasal spray
Intranasal administration of oxytocin 24 international units per dose.
Other Names:
  • Oxytocin treatment
Drug: Placebo nasal spray
Intranasal administration of placebo 24 international units per dose.
Other Names:
  • Placebo control
Experimental: High anxiety group (3 doses)
Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with high trait anxiety.
Drug: Oxytocin nasal spray
Intranasal administration of oxytocin 24 international units per dose.
Other Names:
  • Oxytocin treatment
Drug: Placebo nasal spray
Intranasal administration of placebo 24 international units per dose.
Other Names:
  • Placebo control
Experimental: High anxiety group (5 doses)
Oxytocin nasal spray or placebo nasal spray for 5 days,24 IU per day in subjects with high trait anxiety.
Drug: Oxytocin nasal spray
Intranasal administration of oxytocin 24 international units per dose.
Other Names:
  • Oxytocin treatment
Drug: Placebo nasal spray
Intranasal administration of placebo 24 international units per dose.
Other Names:
  • Placebo control
Experimental: Low anxiety group (single dose)
Oxytocin nasal spray or placebo nasal spray of one dose in subjects with low trait anxiety.
Drug: Oxytocin nasal spray
Intranasal administration of oxytocin 24 international units per dose.
Other Names:
  • Oxytocin treatment
Drug: Placebo nasal spray
Intranasal administration of placebo 24 international units per dose.
Other Names:
  • Placebo control
Experimental: Low anxiety group (3 doses)
Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with low trait anxiety.
Drug: Oxytocin nasal spray
Intranasal administration of oxytocin 24 international units per dose.
Other Names:
  • Oxytocin treatment
Drug: Placebo nasal spray
Intranasal administration of placebo 24 international units per dose.
Other Names:
  • Placebo control
Experimental: Low anxiety group (5 doses)
Oxytocin nasal spray or placebo nasal spray for 5 days in subjects with low trait anxiety.
Drug: Oxytocin nasal spray
Intranasal administration of oxytocin 24 international units per dose.
Other Names:
  • Oxytocin treatment
Drug: Placebo nasal spray
Intranasal administration of placebo 24 international units per dose.
Other Names:
  • Placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes between acute and chronic administration of oxytocin on amygdala activity as assessed by fMRI
Time Frame: 5 days
Changes in neural activity between first dose and repeated dose will be assessed over the time course of 5 days
5 days
Changes between acute and chronic administration of oxytocin on amygdala connectivity as assessed by fMRI
Time Frame: 5 days
Changes in neural connectivity between first dose and repeated dose will be assessed over the time course of 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interaction of acute and chronic treatment effects with trait anxiety on neural activity
Time Frame: 5 days
The high and low trait anxiety groups will be compared with respect to differences in the acute effects (single dose, day 1) and changes of effects with chronic treatment over the course of 5 days.
5 days
Interaction of acute and chronic treatment effects with trait anxiety on neural connectivity
Time Frame: 5 days
The high and low trait anxiety groups will be compared with respect to differences in the acute effects (single dose, day 1) and changes of effects with chronic treatment over the course of 5 days.
5 days
Effects of oxytocin on arousal ratings of emotional stimuli (acute and changes with chronic treatment)
Time Frame: 5 days
Subjects will rate arousal of emotional stimuli using Likert Scales
5 days
Effects of oxytocin on valence ratings of emotional stimuli (acute and changes with chronic treatment)
Time Frame: 5 days
Subjects will rate valence of emotional stimuli using Likert Scales
5 days
Interaction of treatment effects on valence ratings with trait anxiety (acute and changes with chronic treatment)
Time Frame: 5 days
The high and low trait anxiety groups will be compared with respect to differences in the acute (single dose, day 1) treatment effects and changes with chronic treatment (5 days)
5 days
Interaction of treatment effects on arousal ratings with trait anxiety (acute and changes with chronic treatment)
Time Frame: 5 days
The high and low trait anxiety groups will be compared with respect to differences in the acute (single dose, day 1) treatment effects and changes with chronic treatment (5 days)
5 days

Collaborators and Investigators

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

Sponsor

University of Electronic Science and Technology of China

Investigators

  • Principal Investigator: Keith Kendrick, PhD, University of Electronic Science and Technology of China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 3, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

March 14, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UESTC-neuSCAN_10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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