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The purpose of this study is to learn more about how the hormone, oxytocin, impacts social behavior in terms of cooperation with others, attention processing, and reward processing, among patients with social anxiety disorder. Based on available research, the investigators predict that in patients with social anxiety disorder, oxytocin will improve social cooperation during an online ball-tossing game called Cyberball, reduce attention toward socially threatening cues during a dot-probe task, and lead to greater willingness to work for monetary rewards for others rather than themselves during an effort expenditure task.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | Liquid intranasal oxytocin, 24 IU, administered once |
|
| Placebo | Placebo Comparator | Matched placebo nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Liquid metered-dose nasal spray, 24 IU, administered once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Social Cooperation | The outcome measure involved difference scores in the number of balls tossed to Player 1 between two conditions of the task. Across both conditions, the participant (always assigned as "Player 2") played with 3 other on-line players in real time. In Condition 1, Player 1 was programmed to toss on average 70% of his balls to the participant. In Condition 2, Player 1's behavior switched such that he was programmed to toss on average only 10% of his balls to the participant. The data reported below is the number of balls tossed to Player 1 in Condition 2 minus balls tossed under Condition 1. | Day 1 (first day oxytocin or placebo was administered) |
| Disengagement From Social Threat Cues | The outcome measure involved difference scores in response latencies on disengagement trials for disgust versus neutral cues. Difference scores were calculated as response latencies during disengagement trials for disgust cues minus response latencies during disengagement trials for neutral cues. Negative change scores represent an improvement in disengagement. | Day 1 (first day oxytocin or placebo was administered) |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Trust Scores on a 1-7 Likert Scale | Participants will rate their perceived level of trust (on a 1-7 Likert scale) toward Player 1 during online ball-tossing task. Higher ratings on this scale reflect greater perceived trust toward Player 1. | Day 1 (first day oxytocin or placebo was administered) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Anxiety and Related Disorders at Boston University | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28559206 | Derived | Fang A, Treadway MT, Hofmann SG. Working hard for oneself or others: Effects of oxytocin on reward motivation in social anxiety disorder. Biol Psychol. 2017 Jul;127:157-162. doi: 10.1016/j.biopsycho.2017.05.015. Epub 2017 May 27. |
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Although 60 participants were enrolled in the study, 6 participants were found to be ineligible due to meeting criteria for substance dependence (n=2), a primary diagnosis of posttraumatic stress disorder (n=1), and not meeting criteria for social anxiety disorder (n=3). Therefore, only 54 participants were assigned to groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin | Liquid intranasal oxytocin, 24 IU, administered once Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once |
| FG001 | Placebo | Matched placebo nasal spray Placebo: Matched placebo nasal spray |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin | Liquid intranasal oxytocin, 24 IU, administered once Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once |
| BG001 | Placebo | Matched placebo nasal spray Placebo: Matched 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, Categorical | Count of Participants |
| 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 | Social Cooperation | The outcome measure involved difference scores in the number of balls tossed to Player 1 between two conditions of the task. Across both conditions, the participant (always assigned as "Player 2") played with 3 other on-line players in real time. In Condition 1, Player 1 was programmed to toss on average 70% of his balls to the participant. In Condition 2, Player 1's behavior switched such that he was programmed to toss on average only 10% of his balls to the participant. The data reported below is the number of balls tossed to Player 1 in Condition 2 minus balls tossed under Condition 1. | Data from 2 participants could not be analyzed due to technical difficulties with the computer task. Thus, the number of participants analyzed was 52 in total, rather than 54. | Posted | Mean | Standard Deviation | Ball tosses | Day 1 (first day oxytocin or placebo was administered) |
|
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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 | Liquid intranasal oxytocin, 24 IU, administered once Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jitteriness/restlessness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stefan G. Hofmann | Boston University | 617-353-9233 | shofmann@bu.edu |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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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 |
Matched placebo nasal spray |
|
| Perceived Empathy Scores on a 1-7 Likert Scale |
Participants will rate their level of perceived empathy (on a 1-7 Likert scale) with Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived empathy toward Player 1. |
| Day 1 (first day oxytocin or placebo was administered) |
| Perceived Preference Scores on a 1-7 Likert Scale | Participants will rate their level of preference (on a 1-7 Likert scale) for Player 1 during online ball-tossing task. Higher scores on this scale reflect greater preference for Player 1. | Day 1 (first day oxytocin or placebo was administered) |
| Perceived Rejection Scores on a 1-7 Likert Scale | Participants will rate their level of perceived rejection (on a 1-7 Likert scale) from Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived rejection from Player 1. | Day 1 (first day oxytocin or placebo was administered) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once
| OG001 | Placebo | Matched placebo nasal spray Placebo: Matched placebo nasal spray |
|
|
| Primary | Disengagement From Social Threat Cues | The outcome measure involved difference scores in response latencies on disengagement trials for disgust versus neutral cues. Difference scores were calculated as response latencies during disengagement trials for disgust cues minus response latencies during disengagement trials for neutral cues. Negative change scores represent an improvement in disengagement. | Posted | Mean | Standard Deviation | Milliseconds | Day 1 (first day oxytocin or placebo was administered) |
|
|
|
| Secondary | Perceived Trust Scores on a 1-7 Likert Scale | Participants will rate their perceived level of trust (on a 1-7 Likert scale) toward Player 1 during online ball-tossing task. Higher ratings on this scale reflect greater perceived trust toward Player 1. | Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Day 1 (first day oxytocin or placebo was administered) |
|
|
|
| Secondary | Perceived Empathy Scores on a 1-7 Likert Scale | Participants will rate their level of perceived empathy (on a 1-7 Likert scale) with Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived empathy toward Player 1. | Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Day 1 (first day oxytocin or placebo was administered) |
|
|
|
| Secondary | Perceived Preference Scores on a 1-7 Likert Scale | Participants will rate their level of preference (on a 1-7 Likert scale) for Player 1 during online ball-tossing task. Higher scores on this scale reflect greater preference for Player 1. | Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Day 1 (first day oxytocin or placebo was administered) |
|
|
|
| Secondary | Perceived Rejection Scores on a 1-7 Likert Scale | Participants will rate their level of perceived rejection (on a 1-7 Likert scale) from Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived rejection from Player 1. | Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in this analysis. Thus, only 52 participants were included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Day 1 (first day oxytocin or placebo was administered) |
|
|
|
| 0 |
| 27 |
| 7 |
| 27 |
| EG001 | Placebo | Matched placebo nasal spray Placebo: Matched placebo nasal spray | 0 | 27 | 9 | 27 |
| Anxiety | Nervous system disorders | Systematic Assessment |
|
| Dry mouth | Nervous system disorders | Systematic Assessment |
|
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |