HealthyNCT02682888
Trait Anxiety and Defensive Networks
A study testing trait anxiety scale and Oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
to examine the association between trait and defensive network connectivity and the modulatory effect of oxytocin on it Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- trait anxiety scale and Oxytocin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2015to 20 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorders
Who cannot join
- females should not be pregnant or during menstruation.
Trial locations and contacts
1 site in 1 country.
China1 site
school of life science and technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054
About this study
Official title: Trait Anxiety Modulates Resting State Functional Connectivity of Defensive Networks
to examine the association between trait and defensive network connectivity and the modulatory effect of oxytocin on it
Read the 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trait anxiety scaleBehavioural
splitting subjects into 2 groups according to scores of the trait anxiety scale
OxytocinDrug
intranasal administration of oxytocin
PlaceboDrug
intranasal administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| high trait anxiety group | Experimental | experiment 1: identified according to scores of the trait anxiety scale. Receives: Behavioral: trait anxiety scale |
| low trait anxiety group | Experimental | experiment 1: identified according to scores of the trait anxiety scale. Receives: Behavioral: trait anxiety scale |
| oxytocin group | Experimental | experiment 2: intranasal administration of oxytocin Receives: Drug: Oxytocin |
| placebo control group | Placebo comparator | experiment 2: intranasal administration of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the resting state functional connectivity changes in the defensive network
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start8 Dec 2015
- Primary completion19 Aug 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Kendrick, University of Electronic Science and Technology of China
- Investigators
- Keith Kendrick, Dr., Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682888
- Sponsor's protocol ID
- UESTC-neuSCAN_20
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2016
- Last updated
- 11 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trait Anxiety Modulates Resting State Functional Connectivity of Defensive Networks
- ClinicalTrials.gov ID
- NCT02682888
- Acronym / sponsor ID
- UESTC-neuSCAN_20
- Conditions
- Healthy
- Keywords
- brain functional connectivity changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to examine the association between trait and defensive network connectivity and the modulatory effect of oxytocin on it
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high trait anxiety group | Experimental | Behavioral: trait anxiety scaleexperiment 1: identified according to scores of the trait anxiety scale. |
| low trait anxiety group | Experimental | Behavioral: trait anxiety scaleexperiment 1: identified according to scores of the trait anxiety scale. |
| oxytocin group | Experimental | Drug: Oxytocinexperiment 2: intranasal administration of oxytocin |
| placebo control group | Placebo comparator | Drug: Placeboexperiment 2: intranasal administration of placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects without past or current psychiatric or neurological disorders
Key exclusion criteria (1 listed)
- females should not be pregnant or during menstruation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trait anxiety scalesplitting subjects into 2 groups according to scores of the trait anxiety scale | Behavioural | high trait anxiety group, low trait anxiety group |
| Oxytocinintranasal administration of oxytocin | Drug | oxytocin group |
| Placebointranasal administration of placebo | Drug | placebo control group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Kendrick, Dr. principal investigator
University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trait anxiety scale and Oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the resting state functional connectivity changes in the defensive network (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.