| Registry | NCT06329037 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, basic science |
| Enrollment | 80 (Estimated) |
| Sponsor | University of Electronic Science and Technology of China (Other) |
| Conditions | Healthy |
| Interventions | Vasopressin, Placebo (Drug) |
| Dates | start 2024-03-05, primary completion 2025-06-01 (estimated), completion 2025-07-30 (estimated), first posted 2024-03-25, last updated 2024-04-11 |
| Locations | 1 site in China |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Vasopressin group | Experimental | Drug: Vasopressin | Vasopressin (20IU) |
| Placebo group | Placebo comparator | Drug: Placebo | Placebo |
Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| University of Electronic Science and Technology of China | Chengdu, Sichuan | China | Recruiting |