HealthyNCT06329037
The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study
A study testing Vasopressin 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 present study is to investigate the effects of orally administered vasopressin (AVP) on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vasopressin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2024to 30 Jul 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent.
- Normal or corrected-normal version
Who cannot join
- History of neuropsychiatric diseases.
- History of cardiac disease, including arrhythmias, aortic stenosis, or congestive heart failure; history of syncope or unexplained loss of consciousness.
- History of hepatic diseases, including cholestasis, biliary obstructive disease, or severe liver dysfunction.
- History of renal diseases, including renal stones or renal failure.
- History of hyponatremia(Serum sodium <135mmol/L) or hyperkalemia (Serum potassium>5.5mmol/L); history of diabetes mellitus or diabetes insipidus
- Known hypersensitivity or allergic reaction to any medication or hormone; strong allergic reaction to food.
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- Infections such as COVID-19 or influenza, or unexplained fever.
- Subjects with hypertension (BP ≥130/80mmHg) or hypotension (BP ≤ 90/60mmHg).
- History of alcohol or drug abuse; smoker (≥ 10 cigarettes or ≥ 3 cigars or ≥ 3 pipes/day); smoker using e-cigarettes.
- Blood donation (≤ 1 month prior to administration).
- Take oral contraceptives or receive hormonal medications in the three months prior to the experiment.
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
Weihua Zhao, Dr, 86-28-61830811, zarazhao.uestc@outlook.com
About this study
The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design.
Read the detailed description
Animal models and initial findings in humans suggest a role of the AVP signaling system in socio-emotional processes. Initial studies have employed intranasal AVP during a socio-emotional eye tracking paradigm and reported effects on both, top-down as well as bottom-up control. Within this context the present study aims to validate the effects of orally administered AVP on top-down and bottom-up attentional control towards socio-affective stimuli. To this end, healthy individuals will undergo a double-blind, between-subjects, placebo-controlled pharmaco-eye-tracking experiment and receive a single oral dose of vasopressin (20 IU) or placebo before performing a saccade/anti-saccade task 45 minutes after administration. The task paradigm will encompass social (happy, angry, fearful, sad and neutral faces) and non-social (oval) stimuli to examine the social and emotion-specific effects of oral vasopressin.
- Conditions
- Healthy
- Being tested
- Vasopressin, Placebo
- Keywords
- Eye-tracking, vasopressin
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
Also called Antidiuretic Hormone
Administration of Vasopressin (20 IU) (oral spray)
PlaceboDrug
Also called Placebo treatment
Administration of Placebo (oral spray)
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin group | Experimental | Vasopressin (20IU) Receives: Drug: Vasopressin |
| Placebo group | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saccade/antisaccade latency difference between social and non-social stimuli after oral vasopressin administration
Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the vasopressin and placebo treatment conditions.
Measured: 45 minutes - 75 minutes after treatment
Error rate of saccade/antisaccade for social versus non-social stimuli after oral vasopressin administration
Comparison between social-specific error rates of saccade/antisaccade between the vasopressin and placebo treatment conditions.
Measured: 45 minutes - 75 minutes after treatment
Secondary outcomes (2)
Saccade/antisaccade latency for different facial emotions after oral vasopressin administration
Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the vasopressin and placebo treatment conditions.
Measured: 45 minutes - 75 minutes after treatment
Error rate of saccade/antisaccade for different facial emotions after oral vasopressin administration
Comparison between emotion-specific saccade/antisaccade error rates between the vasopressin and placebo treatment conditions.
Measured: 45 minutes - 75 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start5 Mar 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Jul 2025 (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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled double-blind between-subject design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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, Benjamin Becker, University of Electronic Science and Technology of China
- Investigators
- Benjamin Becker, Dr, Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329037
- Sponsor's protocol ID
- BAM_lab_eye-tracking_01
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2024
- Last updated
- 11 Apr 2024
- 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 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study
- ClinicalTrials.gov ID
- NCT06329037
- Acronym / sponsor ID
- BAM_lab_eye-tracking_01
- Conditions
- Healthy
- Keywords
- Eye-tracking, vasopressin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 25 Mar 2024 (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 present study is to investigate the effects of orally administered vasopressin (AVP) on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design.
Detailed description
Animal models and initial findings in humans suggest a role of the AVP signaling system in socio-emotional processes. Initial studies have employed intranasal AVP during a socio-emotional eye tracking paradigm and reported effects on both, top-down as well as bottom-up control. Within this context the present study aims to validate the effects of orally administered AVP on top-down and bottom-up attentional control towards socio-affective stimuli. To this end, healthy individuals will undergo a double-blind, between-subjects, placebo-controlled pharmaco-eye-tracking experiment and receive a single oral dose of vasopressin (20 IU) or placebo before performing a saccade/anti-saccade task 45 minutes after administration. The task paradigm will encompass social (happy, angry, fearful, sad and neutral faces) and non-social (oval) stimuli to examine the social and emotion-specific effects of oral vasopressin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled double-blind between-subject design
| Arm | Type | Receives |
|---|---|---|
| Vasopressin group | Experimental | Drug: VasopressinVasopressin (20IU) |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent.
- Normal or corrected-normal version
Key exclusion criteria (12 listed)
- History of neuropsychiatric diseases.
- History of cardiac disease, including arrhythmias, aortic stenosis, or congestive heart failure; history of syncope or unexplained loss of consciousness.
- History of hepatic diseases, including cholestasis, biliary obstructive disease, or severe liver dysfunction.
- History of renal diseases, including renal stones or renal failure.
- History of hyponatremia(Serum sodium <135mmol/L) or hyperkalemia (Serum potassium>5.5mmol/L); history of diabetes mellitus or diabetes insipidus
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 |
|---|---|---|
| VasopressinAlso: Antidiuretic HormoneAdministration of Vasopressin (20 IU) (oral spray) | Drug | Vasopressin group |
| PlaceboAlso: Placebo treatmentAdministration of Placebo (oral spray) | Drug | Placebo group |
Primary outcome
Saccade/antisaccade latency difference between social and non-social stimuli after oral vasopressin administration
Time frame: 45 minutes - 75 minutes after treatment
Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the vasopressin and placebo treatment conditions.
Error rate of saccade/antisaccade for social versus non-social stimuli after oral vasopressin administration
Time frame: 45 minutes - 75 minutes after treatment
Comparison between social-specific error rates of saccade/antisaccade between the vasopressin and placebo treatment conditions.
2 secondary outcomes
Saccade/antisaccade latency for different facial emotions after oral vasopressin administration
Time frame: 45 minutes - 75 minutes after treatment
Error rate of saccade/antisaccade for different facial emotions after oral vasopressin administration
Time frame: 45 minutes - 75 minutes after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
Benjamin Becker, 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 Vasopressin 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 2 inclusion and 12 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 11 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weihua Zhao, Dr (86-28-61830811, zarazhao.uestc@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saccade/antisaccade latency difference between social and non-social stimuli after oral vasopressin administration (time frame: 45 minutes - 75 minutes after treatment). 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 11 Apr 2024.