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Trait Anxiety and Defensive Networks

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ClinicalTrials.gov Identifier: NCT02682888
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Keith Kendrick, University of Electronic Science and Technology of China

Brief Summary:
to examine the association between trait and defensive network connectivity and the modulatory effect of oxytocin on it

Condition or disease Intervention/treatment Phase
Healthy Behavioral: trait anxiety scale Drug: Oxytocin Drug: Placebo Not Applicable

Detailed Description:
Individuals with high trait anxiety show stable anxiety proneness even in the absence of real threat, which could be a result of intrinsic hyper-connectivity in the defensive systems. In the present study, healthy subjects' trait anxiety levels will be assessed by the sub-trait inventory of the State-Trait Anxiety Inventory. Then two experiments using resting-state fMRI technique will be conducted to first map how hubs in the defensive systems organized in high anxious individuals in a stimuli-free situation (Experiment 1) and then we will examine the modulatory effect of the intranasal administration of oxytocin on functional connectivity in these independently defined defensive networks (Experiment 2).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Trait Anxiety Modulates Resting State Functional Connectivity of Defensive Networks
Actual Study Start Date : December 8, 2015
Estimated Primary Completion Date : December 8, 2019
Estimated Study Completion Date : December 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: high trait anxiety group
experiment 1: identified according to scores of the trait anxiety scale.
Behavioral: trait anxiety scale
splitting subjects into 2 groups according to scores of the trait anxiety scale

Experimental: low trait anxiety group
experiment 1: identified according to scores of the trait anxiety scale.
Behavioral: trait anxiety scale
splitting subjects into 2 groups according to scores of the trait anxiety scale

Experimental: oxytocin group
experiment 2: intranasal administration of oxytocin
Drug: Oxytocin
intranasal administration of oxytocin

Placebo Comparator: placebo control group
experiment 2: intranasal administration of placebo
Drug: Placebo
intranasal administration of placebo




Primary Outcome Measures :
  1. the resting state functional connectivity changes in the defensive network [ Time Frame: one day ]
    The resting-state activity can be accessed using functional magnetic resonance imaging (fMRI) by measuring spontaneous and low-frequency fluctuations (< 0.1 Hz) when the brain is at rest. Group differences will be calculated in the high trait anxiety group relative to the low trait anxiety group and in the oxytocin group relative to the placebo group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

  • females should not be pregnant or during menstruation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682888


Contacts
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Contact: Keith Kendrick, Dr. kkendrick@uestc.edu.cn

Locations
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China, Sichuan
school of life science and technology, University of Electronic Science and Technology of China Recruiting
Chengdu, Sichuan, China, 610054
Contact: Qin Li, Master       helenlee@uestc.edu.cn   
Sponsors and Collaborators
University of Electronic Science and Technology of China
Investigators
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Principal Investigator: Keith Kendrick, Dr. University of Electronic Science and Technology of China
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Responsible Party: Keith Kendrick, Prof., University of Electronic Science and Technology of China
ClinicalTrials.gov Identifier: NCT02682888    
Other Study ID Numbers: UESTC-neuSCAN_20
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by Keith Kendrick, University of Electronic Science and Technology of China:
brain functional connectivity changes
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs