- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04320706
Oral Oxytocin Modulation of Responses to Emotional Stimuli
March 27, 2020 updated by: Keith Kendrick, University of Electronic Science and Technology of China
Oral Oxytocin Modulation of Brain and Behavioral Responses to Emotional Stimuli in Healthy Men
The main aim of the study is to investigate whether orally administered oxytocin (24IU) can modulate neural and behavioral responses to positive and negative valence stimuli during basal (emotional scenes) and higher order (facial stimuli) emotional processing.
Study Overview
Detailed Description
A number of previous studies have reported both neural and social cognition effects of intranasally administered oxytocin, although it is unclear whether functional effects are mediated by the peptide directly entering the brain or indirectly via raising peripheral concentrations.
The investigators hypothesize that one 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 current 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 will be required to complete both face emotion and emotional scene processing tasks during fMRI scanning.
After the tasks, subjects will be required to rate their valence, intensity and arousal response to the same emotional face and scene stimuli which were presented during MRI acquisition.
Blood samples will be taken before and 30 min after the oral treatment interventions to assess oxytocin blood concentrations.
All subjects will be asked to complete a range of questionnaires before treatment to control for possible pre-treatment confounders in terms of personality traits and mood: Beck Depression Inventory II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), the Second Version of Social Responsiveness Scale(SRS-2), and Interpersonal Reactivity Index (IRI).
Study Type
Interventional
Enrollment (Anticipated)
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 Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610054
- Recruiting
- School of Life Science and Technology, University of Electronic Science and Technology of China
-
-
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
17 years to 32 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy subjects without any past or present psychiatric or neurological disorders
Exclusion Criteria:
- History of brain injury
- Head trauma
- Substance abuse
- Medication
- fMRI contraindications (e.g. metal implants)
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral Oxytocin
Oxytocin orally (24 IU)
|
Administration of oxytocin (24 international units) orally
|
Placebo Comparator: Oral Placebo
Placebo orally (identical ingredients, except the active agent)
|
Administration of placebo orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of oral oxytocin administration of oxytocin on neural responses to positive and negative valence emotional faces, as assessed by task fMRI
Time Frame: 45-90 minutes after treatment
|
Comparison of neural activation as assessed by functional MRI on the whole brain level between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo) x emotion (happy, neutral, angry, fear) ANOVAs and emotion-specific comparisons between the treatment groups.
We hypothesized that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on neural systems involved in emotional and brain reward processing.
If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively a different pattern of functional effects.
|
45-90 minutes after treatment
|
Effect of oral oxytocin administration on neural responses to positive and negative valence scenes, as assessed by fMRI
Time Frame: 45-90 minutes after treatment
|
Comparison of neural activation as assessed by functional MRI on whole brain level between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo) x emotion (neutral, positive, negative) ANOVAs and emotion-specific post hoc comparisons between the treatment groups.
We hypothesize that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on neural systems involved in emotional and brain reward processing.
If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively a different pattern of functional effects.
|
45-90 minutes after treatment
|
Effect of oral oxytocin administration on behavioral ratings of face emotion and scene stimuli
Time Frame: 45-115 minutes after treatment
|
Comparison of behavioral ratings of valence, arousal and intensity (9-point Likert scale) for emotional face and social scene stimuli presented again post-scan will be performed in oxytocin versus placebo control groups.
We hypothesize that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on behavioral ratings of positive and negative valence emotional stimuli.
If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively in a different pattern of functional effects.
|
45-115 minutes after treatment
|
Change in blood oxytocin concentrations following oral administration of oxytocin
Time Frame: 30 minutes before treatment and 30 minutes after treatment
|
Changes in blood concentrations of oxytocin from baseline after oral oxytocin treatment will be assessed by comparison with the placebo group.
We hypothesize that oral oxytocin should produce a significant increase in blood oxytocin concentrations after 30 minutes.
|
30 minutes before treatment and 30 minutes after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlations between neural responses/functional connectivity changes and post-scan behavioral ratings
Time Frame: 45-115 minutes after treatment
|
Correlations between neural responses changes and post-scan behavioral ratings of positive and negative valence stimuli will be performed using Pearson correlation in both oxytocin and placebo groups.
We hypothesize that neural responses and behavioral ratings will be correlated.
|
45-115 minutes after treatment
|
Correlations between neural responses/functional connectivity in response to positive and negative valence stimuli and basal and oral administration evoked changes in blood concentrations of oxytocin
Time Frame: 30 minutes before treatment to 90 minutes after treatment
|
Correlations between neural responses in response to positive and negative valence stimuli and basal and oral administration evoked changes in blood concentrations of oxytocin will be performed using Pearson correlation in both oxytocin and placebo groups.
We hypothesize that neural responses to emotional stimuli will correlate with basal and/or oral administration evoked oxytocin concentrations.
|
30 minutes before treatment to 90 minutes after treatment
|
Correlations between behavioral ratings of positive and negative valence stimuli and basal and oral administration evoked changes in blood oxytocin concentrations
Time Frame: 30 minutes before treatment to 115 minutes after treatment
|
Correlations between behavioral ratings of positive and negative valence stimuli and basal and oral administration evoked changes in blood oxytocin concentrations will be performed using Pearson correlation in both oxytocin and placebo groups.
We hypothesize that behavioral ratings to emotional stimuli will correlate with basal and/or oral administration evoked oxytocin concentrations.
|
30 minutes before treatment to 115 minutes after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Keith Kendrick, PhD, 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)
February 20, 2020
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
March 1, 2021
Study Registration Dates
First Submitted
March 21, 2020
First Submitted That Met QC Criteria
March 21, 2020
First Posted (Actual)
March 25, 2020
Study Record Updates
Last Update Posted (Actual)
March 31, 2020
Last Update Submitted That Met QC Criteria
March 27, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-60
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Oral Oxytocin
-
University of Electronic Science and Technology...Recruiting
-
University of Electronic Science and Technology...Recruiting
-
University of Electronic Science and Technology...Recruiting
-
University of Electronic Science and Technology...Recruiting
-
University of Electronic Science and Technology...Unknown
-
University of Electronic Science and Technology...Completed
-
Massachusetts General HospitalCompletedAutism Spectrum DisorderUnited States
-
University of PretoriaCompletedPrevention of Post Partum HaemorrhageSouth Africa
-
University of FloridaRecruiting
-
University of Wisconsin, MadisonRecruitingInduction of Labor Affected Fetus / Newborn | Premature Rupture of MembraneUnited States