HealthyEarly Phase 1NCT03085654
Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety
A Early Phase 1 study testing Oxytocin nasal spray in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
To examine whether multiple doses of oxytocin have different effects on behavior and neural indices in males with high or low trait anxiety. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2017to 30 Apr 2018
- Phase
- Early Phase 1
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adult males
Who cannot join
- past or current psychiatric or neurological disorder
- head trauma
- substance abuse
- medication
- fMRI contraindications (e.g. metal implants)
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
To examine whether multiple doses of oxytocin have different effects on behavior and neural indices in males with high or low trait anxiety.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Oxytocin nasal spray, Placebo nasal spray
- Keywords
- multiple doses, oxytocin, trait anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Also called Oxytocin treatment
Intranasal administration of oxytocin 24 international units per dose.
Placebo nasal sprayDrug
Also called Placebo control
Intranasal administration of placebo 24 international units per dose.
| Study group | Role | What they receive |
|---|---|---|
| High anxiety group (single dose) | Experimental | Oxytocin nasal spray or placebo nasal of one dose in subjects with high trait anxiety. Receives: Drug: Oxytocin nasal spray; Drug: Placebo nasal spray |
| High anxiety group (3 doses) | Experimental | 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. Receives: Drug: Oxytocin nasal spray; Drug: Placebo nasal spray |
| High anxiety group (5 doses) | Experimental | Oxytocin nasal spray or placebo nasal spray for 5 days,24 IU per day in subjects with high trait anxiety. Receives: Drug: Oxytocin nasal spray; Drug: Placebo nasal spray |
| Low anxiety group (single dose) | Experimental | Oxytocin nasal spray or placebo nasal spray of one dose in subjects with low trait anxiety. Receives: Drug: Oxytocin nasal spray; Drug: Placebo nasal spray |
| Low anxiety group (3 doses) | Experimental | 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. Receives: Drug: Oxytocin nasal spray; Drug: Placebo nasal spray |
| Low anxiety group (5 doses) | Experimental | Oxytocin nasal spray or placebo nasal spray for 5 days in subjects with low trait anxiety. Receives: Drug: Oxytocin nasal spray; Drug: Placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes between acute and chronic administration of oxytocin on amygdala activity as assessed by fMRI
Changes in neural activity between first dose and repeated dose will be assessed over the time course of 5 days
Measured: 5 days
Changes between acute and chronic administration of oxytocin on amygdala connectivity as assessed by fMRI
Changes in neural connectivity between first dose and repeated dose will be assessed over the time course of 5 days
Measured: 5 days
Secondary outcomes (6)
Interaction of acute and chronic treatment effects with trait anxiety on neural activity
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.
Measured: 5 days
Interaction of acute and chronic treatment effects with trait anxiety on neural connectivity
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.
Measured: 5 days
Effects of oxytocin on arousal ratings of emotional stimuli (acute and changes with chronic treatment)
Subjects will rate arousal of emotional stimuli using Likert Scales
Measured: 5 days
Effects of oxytocin on valence ratings of emotional stimuli (acute and changes with chronic treatment)
Subjects will rate valence of emotional stimuli using Likert Scales
Measured: 5 days
Interaction of treatment effects on valence ratings with trait anxiety (acute and changes with chronic treatment)
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)
Measured: 5 days
Interaction of treatment effects on arousal ratings with trait anxiety (acute and changes with chronic treatment)
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)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start3 Mar 2017
- Primary completion31 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 147 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, PhD, Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085654
- Sponsor's protocol ID
- UESTC-neuSCAN_10
- Status last verified
- Oct 2018
- First submitted
- 15 Apr 2016
- Last updated
- 29 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kou J, Zhang Y, Zhou F, Gao Z, Yao S, Zhao W, Li H, Lei Y, Gao S, Kendrick KM, Becker B. Anxiolytic Effects of Chronic Intranasal Oxytocin on Neural Responses to Threat Are Dose-Frequency Dependent. Psychother Psychosom. 2022;91(4):253-264. doi: 10.1159/000521348. Epub 2022 Jan 27.
PubMed 35086102
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety
- ClinicalTrials.gov ID
- NCT03085654
- Acronym / sponsor ID
- UESTC-neuSCAN_10
- Conditions
- Healthy
- Keywords
- multiple doses, oxytocin, trait anxiety
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 21 Mar 2017 (actual)
- 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 whether multiple doses of oxytocin have different effects on behavior and neural indices in males with high or low trait anxiety.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| High anxiety group (single dose) | Experimental | Drug: Oxytocin nasal spray, Drug: Placebo nasal sprayOxytocin nasal spray or placebo nasal of one dose in subjects with high trait anxiety. |
| High anxiety group (3 doses) | Experimental | Drug: Oxytocin nasal spray, Drug: Placebo nasal sprayOxytocin 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. |
| High anxiety group (5 doses) | Experimental | Drug: Oxytocin nasal spray, Drug: Placebo nasal sprayOxytocin nasal spray or placebo nasal spray for 5 days,24 IU per day in subjects with high trait anxiety. |
| Low anxiety group (single dose) | Experimental | Drug: Oxytocin nasal spray, Drug: Placebo nasal sprayOxytocin nasal spray or placebo nasal spray of one dose in subjects with low trait anxiety. |
| Low anxiety group (3 doses) | Experimental | Drug: Oxytocin nasal spray, Drug: Placebo nasal sprayOxytocin 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. |
| Low anxiety group (5 doses) | Experimental | Drug: Oxytocin nasal spray, Drug: Placebo nasal sprayOxytocin nasal spray or placebo nasal spray for 5 days in subjects with low trait anxiety. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy adult males
Key exclusion criteria (5 listed)
- past or current psychiatric or neurological disorder
- head trauma
- substance abuse
- medication
- fMRI contraindications (e.g. metal implants)
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 |
|---|---|---|
| Oxytocin nasal sprayAlso: Oxytocin treatmentIntranasal administration of oxytocin 24 international units per dose. | Drug | High anxiety group (3 doses), High anxiety group (5 doses), High anxiety group (single dose), Low anxiety group (3 doses), Low anxiety group (5 doses), Low anxiety group (single dose) |
| Placebo nasal sprayAlso: Placebo controlIntranasal administration of placebo 24 international units per dose. | Drug | High anxiety group (3 doses), High anxiety group (5 doses), High anxiety group (single dose), Low anxiety group (3 doses), Low anxiety group (5 doses), Low anxiety group (single dose) |
Primary outcome
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
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
6 secondary outcomes
Interaction of acute and chronic treatment effects with trait anxiety on neural activity
Time frame: 5 days
Interaction of acute and chronic treatment effects with trait anxiety on neural connectivity
Time frame: 5 days
Effects of oxytocin on arousal ratings of emotional stimuli (acute and changes with chronic treatment)
Time frame: 5 days
Effects of oxytocin on valence ratings of emotional stimuli (acute and changes with chronic treatment)
Time frame: 5 days
Interaction of treatment effects on valence ratings with trait anxiety (acute and changes with chronic treatment)
Time frame: 5 days
Interaction of treatment effects on arousal ratings with trait anxiety (acute and changes with chronic treatment)
Time frame: 5 days
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 29 Oct 2018.
- Derived from this study: PubMed 35086102Kou J, Zhang Y, Zhou F, Gao Z, Yao S, Zhao W, Li H, Lei Y, Gao S, Kendrick KM, Becker B. Anxiolytic Effects of Chronic Intranasal Oxytocin on Neural Responses to Threat Are Dose-Frequency Dependent. Psychother Psychosom. 2022;91(4):253-264. doi: 10.1159/000521348. Epub 2022 Jan 27.
- Individual participant dataSharing planned: No
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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, PhD 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 Early Phase 1 study testing Oxytocin nasal spray 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 5 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 29 Oct 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes between acute and chronic administration of oxytocin on amygdala activity as assessed by fMRI (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085654, which also lists 1 linked publication.
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 29 Oct 2018.