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Completed

NCT Number: NCT03085654

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

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

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

school of life science and technology, University of Electronic Science and Technology of China

Chengdu, Sichuan, 610054, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • healthy adult males

Exclusion:

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

Treatment and study plan

Oxytocin nasal spray

Drug

Intranasal administration of oxytocin 24 international units per dose.

Other names: Oxytocin treatment

Placebo nasal spray

Drug

Intranasal administration of placebo 24 international units per dose.

Other names: Placebo control

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

University of Electronic Science and Technology of China

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2017
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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