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Oral Oxytocin's Effects on Attention Control

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

Tracking Information
First Submitted Date  ICMJE July 27, 2020
First Posted Date  ICMJE July 30, 2020
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE July 28, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Oxytocin's Effects on Attention Control
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Healthy
Intervention  ICMJE
  • Drug: Oral Oxytocin
    Administration of oxytocin orally (24 IU)
  • Drug: Oral Placebo
    Administration of placebo orally (24 IU)
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 27, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04493515
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE University of Electronic Science and Technology of China
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP