Trial · Interventional

CompletedEarly phase 1Registry data

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

NCTNCT03085654Other idUESTC-neuSCAN_10

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Early phase 1
Enrollment: 147 participants (actual)
Sponsor: University of Electronic Science and Technology of China · Other
Design: Randomized · Double masking
Countries: 1 country
China
Start: 3 Mar 2017
Primary completion: 31 Mar 2018
Completion: 30 Apr 2018
First posted: 21 Mar 2017
Last update posted: 29 Oct 2018
Conditions: Healthy

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019

Ph Early 1
Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety
NCT03085654
3 Mar 2017 to 30 Apr 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To examine whether multiple doses of oxytocin have different effects on behavior and neural indices in males with high or low trait anxiety.

Interventions

Oxytocin nasal sprayDrug
Placebo nasal sprayDrug

Arms6

Experimental
High anxiety group (single dose)
Oxytocin nasal spray or placebo nasal of one dose in subjects with high trait anxiety.
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.
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.
Experimental
Low anxiety group (single dose)
Oxytocin nasal spray or placebo nasal spray of one dose in subjects with low trait anxiety.
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.
Experimental
Low anxiety group (5 doses)
Oxytocin nasal spray or placebo nasal spray for 5 days in subjects with low trait anxiety.

Primary outcomes2

Outcomes the sponsor listed as primary.

Changes between acute and chronic administration of oxytocin on amygdala activity as assessed by fMRI
Time frame · 5 days
Registry description
Changes in neural activity between first dose and repeated dose will be assessed over the time course of 5 days
Changes between acute and chronic administration of oxytocin on amygdala connectivity as assessed by fMRI
Time frame · 5 days
Registry description
Changes in neural connectivity between first dose and repeated dose will be assessed over the time course of 5 days

Secondary outcomes(6)

Interaction of acute and chronic treatment effects with trait anxiety on neural activity
Time frame · 5 days
Registry description
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.
Interaction of acute and chronic treatment effects with trait anxiety on neural connectivity
Time frame · 5 days
Registry description
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.
Effects of oxytocin on arousal ratings of emotional stimuli (acute and changes with chronic treatment)
Time frame · 5 days
Registry description
Subjects will rate arousal of emotional stimuli using Likert Scales
Effects of oxytocin on valence ratings of emotional stimuli (acute and changes with chronic treatment)
Time frame · 5 days
Registry description
Subjects will rate valence of emotional stimuli using Likert Scales
Interaction of treatment effects on valence ratings with trait anxiety (acute and changes with chronic treatment)
Time frame · 5 days
Registry description
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)
Interaction of treatment effects on arousal ratings with trait anxiety (acute and changes with chronic treatment)
Time frame · 5 days
Registry description
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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

1 result

Anxiolytic Effects of Chronic Intranasal Oxytocin on Neural Responses to Threat Are Dose-Frequency Dependent.

Kou et al. 2022Psychotherapy and psychosomaticscited by 47

PMID 35086102DOI 10.1159/000521348PUB-35086102

Full text at the publisher1 result

Publisher page See results (1)

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 30 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion: * healthy adult males Exclusion: * past or current psychiatric or neurological disorder * head trauma * substance abuse * medication * fMRI contraindications (e.g. metal implants)

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