Oral Oxytocin's Effects on Attention Control

• ClinicalTrials.gov Identifier: NCT04493515
• Recruitment Status: Unknown
• First Posted: July 30, 2020
• Last Update Posted: July 30, 2020
• Sponsor: University of Electronic Science and Technology of China
• Information provided by (Responsible Party): Keith Kendrick, University of Electronic Science and Technology of China

Tracking Information

• First Submitted Date: July 27, 2020
• First Posted Date: July 30, 2020
• Last Update Posted Date: July 30, 2020
• Actual Study Start Date: July 28, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 27, 2020)

• 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
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 27, 2020)

• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oral Oxytocin's Effects on Attention Control
• Official Title: Oral Oxytocin's Effects on Attention Control: An Eye-tracking Study
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

• Condition: Healthy

Intervention

• Drug: Oral Oxytocin
  Administration of oxytocin orally (24 IU)
• Drug: Oral Placebo
  Administration of placebo orally (24 IU)

Study Arms

• Experimental: Oral Oxytocin
  Oxytocin orally (24 IU)
  Intervention: Drug: Oral Oxytocin
• Placebo Comparator: Oral Placebo
  Placebo orally (24 IU, identical ingredients, except the active agent)
  Intervention: Drug: Oral Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 27, 2020): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2021
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 30 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04493515
• Other Study ID Numbers: UESTC-neuSCAN-69
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Keith Kendrick, University of Electronic Science and Technology of China
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Electronic Science and Technology of China
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Keith Kendrick, PhD; University of Electronic Science and Technology of China (UESTC)

• PRS Account: University of Electronic Science and Technology of China
• Verification Date: July 2020