Clinical trial NCT06329037: The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study
Official title: The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Eye-tracking
vasopressin
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled double-blind between-subject design
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Saccade/antisaccade latency difference between social and non-social stimuli after oral vasopressin administration
timeFrame: 45 minutes - 75 minutes after treatment
measure: Error rate of saccade/antisaccade for social versus non-social stimuli after oral vasopressin administration
timeFrame: 45 minutes - 75 minutes after treatment
Secondary outcomes:
measure: Saccade/antisaccade latency for different facial emotions after oral vasopressin administration
timeFrame: 45 minutes - 75 minutes after treatment
measure: Error rate of saccade/antisaccade for different facial emotions after oral vasopressin administration
timeFrame: 45 minutes - 75 minutes after treatment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Benjamin Becker, Dr
role: PRINCIPAL_INVESTIGATOR
References: