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History of Changes for Study: NCT04493515
Oral Oxytocin's Effects on Attention Control
Latest version (submitted July 27, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 27, 2020 None (earliest Version on record)
Comparison Format:

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Study NCT04493515
Submitted Date:  July 27, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: UESTC-neuSCAN-69
Brief Title: Oral Oxytocin's Effects on Attention Control
Official Title: Oral Oxytocin's Effects on Attention Control: An Eye-tracking Study
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2020
Overall Status: Unknown status [Previously: Recruiting]
Study Start: July 28, 2020
Primary Completion: December 31, 2020 [Anticipated]
Study Completion: December 31, 2021 [Anticipated]
First Submitted: July 27, 2020
First Submitted that
Met QC Criteria:
July 27, 2020
First Posted: July 30, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
July 27, 2020
Last Update Posted: July 30, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Electronic Science and Technology of China
Responsible Party: Principal Investigator
Investigator: Keith Kendrick
Official Title: Professor
Affiliation: University of Electronic Science and Technology of China
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The main aim of the study is to investigate whether orally administered oxytocin (24IU) could modulate attention control using a social-emotional saccade/antisaccade eye-tracking paradigm.
Detailed Description: Numerous studies have reported the effect of intranasally administered oxytocin on attentional processing including stimulus-driven bottom-up processing and top-down goal-directed inhibitory control. However, it is unclear whether the functional effects are mediated by the peptide directly entering the brain or indirectly via raising peripheral concentrations. One possible method of producing a similar pattern of increased peripheral oxytocin concentrations but without the possibility of direct entry into the brain would be to administer the peptide lingually. In the present double-blind, between-subject, placebo-controlled study, 80 healthy male subjects will be recruited and receive either oxytocin (24IU) or placebo control administered orally (lingual). 45 minutes after treatment subjects are required to complete a social-emotional saccade/antisaccade eye-tracking paradigm. This paradigm uses social (happy, sad, angry, fear, and neutral faces) as well as non-social (oval shapes) stimuli to explore social- and emotion-specific effects of orally administered oxytocin.
Open or close this module Conditions
Conditions: Healthy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Oral Oxytocin
Oxytocin orally (24 IU)
Drug: Oral Oxytocin
Administration of oxytocin orally (24 IU)
Placebo Comparator: Oral Placebo
Placebo orally (24 IU, identical ingredients, except the active agent)
Drug: Oral Placebo
Administration of placebo orally (24 IU)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Effect of oral oxytocin administration on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli
[ Time Frame: 45 minutes - 100 minutes after treatment ]

Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the oxytocin and placebo treatment conditions
2. Effect of oral oxytocin administration on error rates of saccade/antisaccade for social (facial) versus non-social (shape) stimuli
[ Time Frame: 45 minutes - 100 minutes after treatment ]

Comparison between social-specific error rates of saccade/antisaccade between the oxytocin and placebo treatment conditions.
Secondary Outcome Measures:
1. Emotion-specific effects of oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions
[ Time Frame: 45 minutes - 100 minutes after treatment ]

Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the oxytocin and placebo treatment conditions
2. Emotion-specific effects of oral oxytocin administration on saccade/antisaccade error rates for the separate facial emotions
[ Time Frame: 45 minutes - 100 minutes after treatment ]

Comparison between emotion-specific saccade/antisaccade error rates between the oxytocin and placebo treatment conditions
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 30 Years
Sex: Male
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Male, healthy participants
  • Non smokers

Exclusion Criteria:

  • Previous or current medical, psychiatric, neurological disorder
  • Regular medication
  • Use of any psychoactive substances in the 24 hours before experiment
  • Contra-indications for oxytocin
  • Contra-indications for eye-tracking data acquisition
Open or close this module Contacts/Locations
Study Officials: Keith Kendrick, PhD
Principal Investigator
University of Electronic Science and Technology of China (UESTC)
Locations: China, Sichuan
University of Electronic Science and Technology of China(UESTC)
Chengdu, Sichuan, China, 611731
Contact:Contact: Zhao Weihua, PhD +86 2861 830 811 zarazhao.uestc@outlook.com
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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