NCT03282162

Brief Summary

The main aim of the study is to investigate whether intranasal oxytocin (24IU) increases the affective processing of touch in general or whether it's effect vary according to the affective valence of the touch (positive, neutral, negative). Moreover, associations with trait autism will be explored.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2017

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 28, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2018

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

September 7, 2017

Last Update Submit

October 26, 2018

Conditions

Healthy

Keywords

Oxytocinaffective touchtrait autism

Outcome Measures

Primary Outcomes (2)

  • brain function: neural activity during affective touch as assessed via BOLD fMRI

    fMRI data will be analyzed using a within-subject General Linear Model approach - to determine the effects of oxytocin neural activity following oxytocin administration will be compared with neural activity following placebo administration.

    45-90 minutes after treatment administration

  • Brain function: functional connectivity during affective touch as assessed via BOLD fMRI

    fMRI data will be analyzed using a within-subject General Linear Model approach - to determine the effects of oxytocin on the brain network level, functional connectivity following oxytocin administration will be compared with functional connectivity following placebo administration.

    45-90 minutes after treatment administration

Secondary Outcomes (7)

  • Perceived affective quality of the touch

    45-90 minutes after treatment administration

  • Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: activity

    45-90 minutes after treatment administration

  • Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: functional connectivity

    45-90 minutes after treatment administration

  • Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - behaviour: pleasantness experience

    45-90 minutes after treatment administration

  • Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: activity

    45-90 minutes after treatment administration

  • +2 more secondary outcomes

Study Arms (2)

Oxytocin then placebo

EXPERIMENTAL

Subjects will first receive oxytocin (24 IU).They then will receive placebo (24 IU) 2 weeks later.

Drug: intranasal oxytocinDrug: intranasal placebo

Placebo then oxytocin

EXPERIMENTAL

Subjects will first receive placebo (24 IU).They then will receive oxytocin (24 IU) 2 weeks later.

Drug: intranasal oxytocinDrug: intranasal placebo

Interventions

intranasal oxytocinDRUG

Each subject will be assigned to intranasal administration of oxytocin (24 IU).

Oxytocin then placeboPlacebo then oxytocin
intranasal placeboDRUG

An identical amount of intranasal administration of placebo will be assigned to each subject.

Oxytocin then placeboPlacebo then oxytocin

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects without any past or present psychiatric or neurological disorders

You may not qualify if:

  • History of brain injury Medical or mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China(UESTC)

Chengdu, Sichuan, 611731, China

Location

Study Officials

  • Yuanshu Chen, B.S.

    University of Electronic Science and Technology of China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized placebo-controlled double-blind within-subject design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 13, 2017

Study Start

August 28, 2017

Primary Completion

January 31, 2018

Study Completion

July 12, 2018

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

CN(1)