NCT06329063

Brief Summary

The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on the perception of time-to-collision of threatening and non-threatening stimuli by combining a validated looming fear eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

March 15, 2024

Last Update Submit

April 9, 2024

Conditions

Keywords

Eye-trackingvasopressinlooming fear

Outcome Measures

Primary Outcomes (1)

  • Ratio of judged-time-to-collision to actual-time-to-collision for threatening versus non-threatening stimuli after oral vasopressin administration

    Comparison of the ratio between the judged time to collision and the actual time to collision between the treatment groups for threatening (spider, snake) and non-threatening (rabbit, butterfly) stimuli.

    75 minutes - 105 minutes after treatment

Secondary Outcomes (2)

  • First saccade latency(ms) for threatening versus non-threatening stimuli after oral vasopressin administration

    75 minutes - 105 minutes after treatment

  • Fixation duration(ms) for threatening versus non-threatening stimuli after oral vasopressin administration

    75 minutes - 105 minutes after treatment

Study Arms (2)

Vasopressin group

EXPERIMENTAL

Drug: Vasopressin (20IU)

Drug: Vasopressin

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Drug: Placebo

Interventions

Administration of vasopressin (20 IU) (oral spray)

Also known as: Antidiuretic Hormone
Vasopressin group

Administration of placebo (oral spray)

Also known as: Placebo treatment
Placebo group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Benjamin Becker, Dr

    University of Electronic Science and Technology of China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Randomized placebo-controlled double-blind between-subject design
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 25, 2024

Study Start

March 5, 2024

Primary Completion

June 1, 2025

Study Completion

July 30, 2025

Last Updated

April 11, 2024

Record last verified: 2024-04

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