- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03610919
Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses
Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses, and Modulation by Trait Autism and Genotype
Study Overview
Detailed Description
In the present study, healthy male subjects will be screened according to the study inclusion criteria. After enrollment buccal swaps will be collected for genotyping and subjects will be randomly assigned to three experimental groups that will receive treatment for 5 subsequent days: (1) placebo for five days, (2) oxytocin on days 1, 3 and 5, or (3) oxytocin for five days. Behavioral measures, task-based and resting fMRI will be assessed after the first treatment (acute effects) and the last treatment (chronic effects). The task-based fMRI will employ an implicit emotional face processing paradigm and ratings of the facial emotions will be collected after the fMRI.
Moreover, to control for potential confounding effects of relevant traits all participants will complete the following questionnaires: Interpersonal Reactivity Index (IRI),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI). To explore potential modulatory effects of trait autism, all subjects will be administered the Autism Spectrum Quotient (ASQ) scale to assess pre-treatment autism traits.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Benjamin Becker, PhD
- Phone Number: +86 2861 830 811
- Email: ben_becker@gmx.de
Study Contact Backup
- Name: Weihua Zhao, PhD
- Phone Number: +86 2861 830 811
- Email: zarazhao.uestc@outlook.com
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610054
- Recruiting
- School of Life Science and Technology, University of Electronic Science and Technology of China
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy adult males
Exclusion Criteria:
- past or current psychiatric or neurological disorder head trauma substance abuse medication fMRI contraindications (e.g. metal implants)
Study Plan
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: Oxytocin nasal spray(5 doses)
Oxytocin nasal spray for 5 days, 24 IU per day
|
Intranasal administration of 24 international units per dose.
|
Experimental: Oxytocin nasal spray(3 doses)
Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day.
|
Intranasal administration of 24 international units per dose.
|
Placebo Comparator: Placebo nasal spray(control group)
Placebo nasal spray for 5 days,24 IU per day.
|
Intranasal administration of 24 international units per dose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala reactivity towards fearful faces as assessed by fMRI.
Time Frame: 45 minutes after treatment (day 1 vs day 5)
|
Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala activity towards fearful faces.
Amygdala activity will be assessed using task-based BOLD fMRI analyses.
|
45 minutes after treatment (day 1 vs day 5)
|
Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala resting state connectivity as assessed by fMRI.
Time Frame: 45 minutes after treatment (day 1 vs day 5)
|
Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala resting state fMRI connectivity.
Amygdala functional connectivity will be examined using a seed to whole brain approach.
|
45 minutes after treatment (day 1 vs day 5)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between trait autism with acute and chronic treatment effects on amygdala activity in response to fearful faces
Time Frame: 45 minutes after treatment (day 1 vs day 5)
|
Associations between autism traits and amygdala response to fearful faces during acute effects (single dose, day 1) and chronic effects (over the course of 5 days) will be examined by means of correlation analyses.
Pre-treatment autism trait scores will be assessed using the Autism Spectrum Quotient (ASQ)
|
45 minutes after treatment (day 1 vs day 5)
|
Association between trait autism with acute and chronic treatment effects on amygdala resting state connectivity
Time Frame: 45 minutes after treatment (day 1 vs day 5)
|
Associations between autism traits and amygdala resting state connectivity during acute effects (single dose, day 1) and chronic effects (over the course of 5 days) will be examined by means of correlation analyses.
Pre-treatment autism trait scores will be assessed using the Autism Spectrum Quotient (ASQ)
|
45 minutes after treatment (day 1 vs day 5)
|
Interaction of acute and chronic treatment effects on amygdala activity with oxytocin receptor genotype.
Time Frame: 45 minutes after treatment (day 1 vs day 5)
|
Participants will be divided in sub-groups according to their oxytocin receptor (OXTR) genetic profile.
Modulatory effects of the OXTR on acute and chronic effects will be explored by comparing effects of treatment on amygdala activity in response to fearful faces as assessed by fMRI between the genotype groups.
|
45 minutes after treatment (day 1 vs day 5)
|
Interaction of acute and chronic treatment effects on amygdala connectivity with oxytocin receptor genotype.
Time Frame: 45 minutes after treatment (day 1 vs day 5)
|
Participants will be divided in sub-groups according to their oxytocin receptor (OXTR) genetic profile.
Modulatory effects of the OXTR on acute and chronic effects will be explored by comparing effects of treatment on amygdala resting state connectivity as assessed by fMRI between the genotype groups.
|
45 minutes after treatment (day 1 vs day 5)
|
Treatment effects on arousal will be assessed by subjects rating their arousal on a 9-point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
Time Frame: 45 minutes after treatment (day 1 vs day 5)
|
After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional arousal of the stimuli using Likert scales (9 point).
Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.
|
45 minutes after treatment (day 1 vs day 5)
|
Treatment effects on valence will be assessed by subjects rating their valence on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
Time Frame: 45 minutes after treatment (day 1 vs day 5)
|
After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional valence of the stimuli using Likert scales (9 point).
Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.
|
45 minutes after treatment (day 1 vs day 5)
|
Treatment effects on intensity will be assessed by subjects rating their intensity on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
Time Frame: 45 minutes after treatment (day 1 vs day 5)
|
After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional intensity of the stimuli using Likert scales (9 point).
Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.
|
45 minutes after treatment (day 1 vs day 5)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Keith Kendrick, PhD, University of Electronic Science and Technology of China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UESTC-neuSCAN-57
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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