Effects of Intranasal Oxytocin on Striatal Functional Con... | NCT03128203

Studies
Effects of Intranasal Oxytocin on Striatal Functional Connectivity

NCT03128203

Sponsor

University of Electronic Science and Technology of China

Status

Completed

Last Update Posted

Apr 25, 2017Actual

Enrollment

135Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Oxytocin
Placebos

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Feb 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Apr 20, 2017

First Submission Date that Met QC Criteria

Apr 20, 2017

First Posted Date

Apr 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2017

Last Update Posted Date

Apr 25, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Benjamin Becker, Professor, University of Electronic Science and Technology of ChinaPrincipal Investigator

Lead Sponsor

University of Electronic Science and Technology of ChinaOTHER

Collaborators

Not provided

Description Module

Brief Summary

To investigate whether 40 IU of intranasal oxytocin treatment can influence the resting-state functional connectivity in healthy males.

Detailed Description

In a double-blind, between-subject, placebo controlled design, investigators plan to investigate the effects of oxytocin treatment on resting-state functional connectivity.

Subject will receive either intranasal oxytocin or placebo administration and go through a seven-minute resting-state scan in MRI scanner to test whether oxytocin changes functional connectivity in the brain. Trait anxiety and mood questionnaires will be administered as control variables.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

135Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxytocin	Experimental		Drug: Oxytocin
Placebo	Placebo Comparator		Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug	Oxytocin, intranasally administrated	Oxytocin
Placebos

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Striatal functional connectivity alterations after drug administration	fMRI-based resting state connectivity of the striatum will be compared between the oxytocin and the placebo group	45 minutes after drug administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

with MRI Contraindications

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin Becker, Dr.	School of Life Science and Technology, University of Electronic Science and Technology of China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Life Science and Technology, University of Electronic Science and Technology of China		Chengdu	Sichuan	611731	China

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided