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This study is designed to investigate oxytocin's effects on interoception and whether these effects vary as a function of different emotional valence.
The present study will use a double-blind, between-subject, placebo-controlled design to investigate the modulatory effect of oxytocin on interoception and whether this effect will vary as a function of emotional valence. In Experiment 1, subjects will perform a heartbeat detection task and the group differences between oxytocin and placebo groups of the interoceptive accuracy and neural activity in the core interoceptive network will be investigated. In Experiment 2, subjects will be asked to watch emotional faces while perform the heartbeat detection task. Investigators will examine whether oxytocin's effects on interoception will be varied as a function of different emotional valence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxytocin | Experimental | intranasal administration of oxytocin |
|
| placebo | Placebo Comparator | intranasal administration of the same ingredient except oxytocin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxytocin | Drug | self-administration of oxytocin (nasal spray) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Heartbeat Detection (Interoception) Accuracy | heartbeat detection (interoception) accuracy is calculated by the following equation: 1/N ∑ (1 - (|recorded heartbeats - counted heartbeats|)/recorded heartbeats). N was the number of blocks for the heartbeat detection task. | 45 minutes after oxytocin/placebo treatment |
| Interoceptive Network Activity | interoceptive network (including anterior insula and dorsal cingulate cortex) activity as measured by the functional MRI technique in the heartbeat detection task. In the heartbeat detection task participants were instructed to make a keypress each time they felt their heartbeat. The interoceptive network activity was indicated by the percentage of BOLD signal change. The value of the percentage of BOLD signal change indicates the level of a certain brain region activated (the involvement of a brain region in a specific cognitive process). | 45 minutes after oxytocin/placebo treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Kendrick, PhD | University of Electronic Science and Technology of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Electronic Science and Technology of China | Chengdu | Sichuan | 611731 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin | intranasal administration of oxytocin oxytocin: self-administration of oxytocin (nasal spray) |
| FG001 | Placebo | intranasal administration of the same ingredient except oxytocin placebo: self-administration of placebo (nasal spray) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
83 subjects were recruited and 8 subjects were excluded due to low quality of electrocardiogram data (6 subjects) or failure of behavioral data acquisition (2 subjects).
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin | intranasal administration of oxytocin oxytocin: self-administration of oxytocin (nasal spray) |
| BG001 | Placebo | intranasal administration of the same ingredient except oxytocin placebo: self-administration of placebo (nasal spray) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heartbeat Detection (Interoception) Accuracy | heartbeat detection (interoception) accuracy is calculated by the following equation: 1/N ∑ (1 - (|recorded heartbeats - counted heartbeats|)/recorded heartbeats). N was the number of blocks for the heartbeat detection task. | 83 subjects were recruited and 8 subjects were excluded due to low quality of electrocardiogram data (6 subjects) or failure of behavioral data acquisition (2 subjects). | Posted | Mean | Standard Error | ratio of correct heartbeat counting | 45 minutes after oxytocin/placebo treatment |
|
Adverse Events were monitored for 2 weeks after subjects finished the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin | intranasal administration of oxytocin oxytocin: self-administration of oxytocin (nasal spray) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shuxia Yao | University of Electronic Science and Technology of China | +8618111297596 | yaoshuxia@uestc.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2018 | Sep 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| placebo |
| Drug |
self-administration of placebo (nasal spray) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
intranasal administration of the same ingredient except oxytocin placebo: self-administration of placebo (nasal spray) |
|
|
| Primary | Interoceptive Network Activity | interoceptive network (including anterior insula and dorsal cingulate cortex) activity as measured by the functional MRI technique in the heartbeat detection task. In the heartbeat detection task participants were instructed to make a keypress each time they felt their heartbeat. The interoceptive network activity was indicated by the percentage of BOLD signal change. The value of the percentage of BOLD signal change indicates the level of a certain brain region activated (the involvement of a brain region in a specific cognitive process). | 83 subjects were recruited and 8 subjects were excluded due to low quality of electrocardiogram data (6 subjects) or failure of behavioral data acquisition (2 subjects). | Posted | Mean | Standard Error | percentage of BOLD signal change | 45 minutes after oxytocin/placebo treatment |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Placebo | intranasal administration of the same ingredient except oxytocin placebo: self-administration of placebo (nasal spray) | 0 | 42 | 0 | 42 | 0 | 42 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |