The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study

Healthy Clinical Trial

Official title:

The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06329037
• Other study ID #: BAM_lab_eye-tracking_01
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: April 2024
• Source: University of Electronic Science and Technology of China
• Contact: Weihua Zhao, Dr
• Phone: 86-28-61830811
• Email: zarazhao.uestc[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 design.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 30, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Vasopressin
Administration of Vasopressin (20 IU) (oral spray)
• Placebo
Administration of Placebo (oral spray)

Locations

Country	Name	City	State
China	University of Electronic Science and Technology of China	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	45 minutes - 75 minutes after treatment
Primary	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.	45 minutes - 75 minutes after treatment
Secondary	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.	45 minutes - 75 minutes after treatment
Secondary	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.	45 minutes - 75 minutes after treatment