HealthyPhase 1NCT03610919
Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses
A Phase 1 study testing Nasal Sprays in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The main aim of the study is to examine effects of different dose frequencies of repeated oxytocin administration on neural and behavioral markers of oxytocin in healthy male subjects. In addition modulatory effects of autism traits and oxytocin receptor genotype (OXTR) will be explored. Read more about this study
- Who is it for?
- Ages 17 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nasal Sprays
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Dec 2018
- Phase
- 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 17 to 30 years
- Men only
- Healthy volunteers accepted
- Child, 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, 1 recruiting
- Recruiting
school of life science and technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054
Weihua Zhao, PhD
About this study
Official title: Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses, and Modulation by Trait Autism and Genotype
The main aim of the study is to examine effects of different dose frequencies of repeated oxytocin administration on neural and behavioral markers of oxytocin in healthy male subjects. In addition modulatory effects of autism traits and oxytocin receptor genotype (OXTR) will be explored.
Read the detailed description
In the present study, healthy male subjects will be screened according to the study inclusion criteria. After enrollment buccal swaps will be collected for genotyping and subjects will be randomly assigned to three experimental groups that will receive treatment for 5 subsequent days: (1) placebo for five days, (2) oxytocin on days 1, 3 and 5, or (3) oxytocin for five days. Behavioral measures, task-based and resting fMRI will be assessed after the first treatment (acute effects) and the last treatment (chronic effects). The task-based fMRI will employ an implicit emotional face processing paradigm and ratings of the facial emotions will be collected after the fMRI.
Moreover, to control for potential confounding effects of relevant traits all participants will complete the following questionnaires: Interpersonal Reactivity Index (IRI),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI). To explore potential modulatory effects of trait autism, all subjects will be administered the Autism Spectrum Quotient (ASQ) scale to assess pre-treatment autism traits.
- Conditions
- Healthy
- Being tested
- Nasal Sprays
- Keywords
- multiple doses, oxytocin, genotype, autism trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal SpraysDrug
Intranasal administration of 24 international units per dose.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin nasal spray(5 doses) | Experimental | Oxytocin nasal spray for 5 days, 24 IU per day Receives: Drug: Nasal Sprays |
| Oxytocin nasal spray(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. Receives: Drug: Nasal Sprays |
| Placebo nasal spray(control group) | Placebo comparator | Placebo nasal spray for 5 days,24 IU per day. Receives: Drug: Nasal Sprays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala reactivity towards fearful faces as assessed by fMRI.
Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala activity towards fearful faces. Amygdala activity will be assessed using task-based BOLD fMRI analyses.
Measured: 45 minutes after treatment (day 1 vs day 5)
Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala resting state connectivity as assessed by fMRI.
Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala resting state fMRI connectivity. Amygdala functional connectivity will be examined using a seed to whole brain approach.
Measured: 45 minutes after treatment (day 1 vs day 5)
Secondary outcomes (7)
Association between trait autism with acute and chronic treatment effects on amygdala activity in response to fearful faces
Associations between autism traits and amygdala response to fearful faces during acute effects (single dose, day 1) and chronic effects (over the course of 5 days) will be examined by means of correlation analyses. Pre-treatment autism trait scores will be assessed using the Autism Spectrum Quotient (ASQ)
Measured: 45 minutes after treatment (day 1 vs day 5)
Association between trait autism with acute and chronic treatment effects on amygdala resting state connectivity
Associations between autism traits and amygdala resting state connectivity during acute effects (single dose, day 1) and chronic effects (over the course of 5 days) will be examined by means of correlation analyses. Pre-treatment autism trait scores will be assessed using the Autism Spectrum Quotient (ASQ)
Measured: 45 minutes after treatment (day 1 vs day 5)
Interaction of acute and chronic treatment effects on amygdala activity with oxytocin receptor genotype.
Participants will be divided in sub-groups according to their oxytocin receptor (OXTR) genetic profile. Modulatory effects of the OXTR on acute and chronic effects will be explored by comparing effects of treatment on amygdala activity in response to fearful faces as assessed by fMRI between the genotype groups.
Measured: 45 minutes after treatment (day 1 vs day 5)
Interaction of acute and chronic treatment effects on amygdala connectivity with oxytocin receptor genotype.
Participants will be divided in sub-groups according to their oxytocin receptor (OXTR) genetic profile. Modulatory effects of the OXTR on acute and chronic effects will be explored by comparing effects of treatment on amygdala resting state connectivity as assessed by fMRI between the genotype groups.
Measured: 45 minutes after treatment (day 1 vs day 5)
Treatment effects on arousal will be assessed by subjects rating their arousal on a 9-point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional arousal of the stimuli using Likert scales (9 point). Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.
Measured: 45 minutes after treatment (day 1 vs day 5)
Treatment effects on valence will be assessed by subjects rating their valence on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional valence of the stimuli using Likert scales (9 point). Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.
Measured: 45 minutes after treatment (day 1 vs day 5)
Treatment effects on intensity will be assessed by subjects rating their intensity on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional intensity of the stimuli using Likert scales (9 point). Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.
Measured: 45 minutes after treatment (day 1 vs day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Mar 2018
- Primary completion1 Sep 2018
- Study completion1 Dec 2018 (estimated)
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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
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
- NCT03610919
- Sponsor's protocol ID
- UESTC-neuSCAN-57
- Status last verified
- Oct 2018
- First submitted
- 16 Jul 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses, and Modulation by Trait Autism and Genotype
- ClinicalTrials.gov ID
- NCT03610919
- Acronym / sponsor ID
- UESTC-neuSCAN-57
- Conditions
- Healthy
- Keywords
- multiple doses, oxytocin, genotype, autism trait
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 1 Aug 2018 (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.
The main aim of the study is to examine effects of different dose frequencies of repeated oxytocin administration on neural and behavioral markers of oxytocin in healthy male subjects. In addition modulatory effects of autism traits and oxytocin receptor genotype (OXTR) will be explored.
Detailed description
In the present study, healthy male subjects will be screened according to the study inclusion criteria. After enrollment buccal swaps will be collected for genotyping and subjects will be randomly assigned to three experimental groups that will receive treatment for 5 subsequent days: (1) placebo for five days, (2) oxytocin on days 1, 3 and 5, or (3) oxytocin for five days. Behavioral measures, task-based and resting fMRI will be assessed after the first treatment (acute effects) and the last treatment (chronic effects). The task-based fMRI will employ an implicit emotional face processing paradigm and ratings of the facial emotions will be collected after the fMRI.
Moreover, to control for potential confounding effects of relevant traits all participants will complete the following questionnaires: Interpersonal Reactivity Index (IRI),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI). To explore potential modulatory effects of trait autism, all subjects will be administered the Autism Spectrum Quotient (ASQ) scale to assess pre-treatment autism traits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxytocin nasal spray(5 doses) | Experimental | Drug: Nasal SpraysOxytocin nasal spray for 5 days, 24 IU per day |
| Oxytocin nasal spray(3 doses) | Experimental | Drug: Nasal SpraysOxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day. |
| Placebo nasal spray(control group) | Placebo comparator | Drug: Nasal SpraysPlacebo nasal spray for 5 days,24 IU per day. |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- healthy adult males
Key exclusion criteria (1 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 |
|---|---|---|
| Nasal SpraysIntranasal administration of 24 international units per dose. | Drug | Oxytocin nasal spray(3 doses), Oxytocin nasal spray(5 doses), Placebo nasal spray(control group) |
Primary outcome
Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala reactivity towards fearful faces as assessed by fMRI.
Time frame: 45 minutes after treatment (day 1 vs day 5)
Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala activity towards fearful faces. Amygdala activity will be assessed using task-based BOLD fMRI analyses.
Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala resting state connectivity as assessed by fMRI.
Time frame: 45 minutes after treatment (day 1 vs day 5)
Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala resting state fMRI connectivity. Amygdala functional connectivity will be examined using a seed to whole brain approach.
7 secondary outcomes
Association between trait autism with acute and chronic treatment effects on amygdala activity in response to fearful faces
Time frame: 45 minutes after treatment (day 1 vs day 5)
Association between trait autism with acute and chronic treatment effects on amygdala resting state connectivity
Time frame: 45 minutes after treatment (day 1 vs day 5)
Interaction of acute and chronic treatment effects on amygdala activity with oxytocin receptor genotype.
Time frame: 45 minutes after treatment (day 1 vs day 5)
Interaction of acute and chronic treatment effects on amygdala connectivity with oxytocin receptor genotype.
Time frame: 45 minutes after treatment (day 1 vs day 5)
Treatment effects on arousal will be assessed by subjects rating their arousal on a 9-point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
Time frame: 45 minutes after treatment (day 1 vs day 5)
Treatment effects on valence will be assessed by subjects rating their valence on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
Time frame: 45 minutes after treatment (day 1 vs day 5)
Treatment effects on intensity will be assessed by subjects rating their intensity on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
Time frame: 45 minutes after treatment (day 1 vs day 5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
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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 Phase 1 study testing Nasal Sprays 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: status not confirmed, 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Becker, PhD (+86 2861 830 811, ben_becker@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala reactivity towards fearful faces as assessed by fMRI. (time frame: 45 minutes after treatment (day 1 vs day 5)). 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?
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.