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

April 9, 2024 updated by: Benjamin Becker, University of Electronic Science and Technology of China
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 611731
        • Recruiting
        • University of Electronic Science and Technology of China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Placebo
Drug: Placebo
Administration of Placebo (oral spray)
Other Names:
  • Placebo treatment
Experimental: Vasopressin group
Vasopressin (20IU)
Drug: Vasopressin
Administration of Vasopressin (20 IU) (oral spray)
Other Names:
  • Antidiuretic Hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45 minutes - 75 minutes after treatment
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.
45 minutes - 75 minutes after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saccade/antisaccade latency for different facial emotions after oral vasopressin administration
Time Frame: 45 minutes - 75 minutes after treatment
Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the vasopressin and placebo treatment conditions.
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
Comparison between emotion-specific saccade/antisaccade error rates between the vasopressin and placebo treatment conditions.
45 minutes - 75 minutes after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Electronic Science and Technology of China

Investigators

  • Principal Investigator: Benjamin Becker, Dr, University of Electronic Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAM_lab_eye-tracking_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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