Social Anxiety Disorder
Conditions
Brief summary
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.
Interventions
DRUGOxytocin
Liquid metered-dose nasal spray, 24 IU, administered once
DRUGPlacebo
Matched placebo nasal spray
Sponsors
Stefan G. Hofmann
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males \> 18 years of age with a primary (or co-principal) psychiatric diagnosis of social anxiety disorder (SAD), as defined by Diagnostic and Statistical Manual-IV (DSM-IV) criteria; * Current Liebowitz Social Anxiety Scale (LSAS) score \> 60, which is a clinical threshold for SAD symptoms; * Comorbid present DSM-IV Major Depression, Dysthymia, Specific Phobia, or any of the other anxiety disorders as diagnosed by DSM-IV criteria will be permitted as long as SAD is primary (the disorder that is most distressing to the patient). Inclusion of patients with comorbidity will permit accrual of a more clinically relevant patient population; * Willingness to participate in and comply with the study procedures as indicated by signing the informed consent form.
Exclusion criteria
* Subjects with a serious medical illness for which hospitalization may be likely within the next three months; * Subjects with a current diagnosis of schizophrenia, psychotic disorders, bipolar disorder, mental disorder due to a medical condition or substance, substance abuse or dependence, as diagnosed by DSM-IV criteria; * Concurrent use of other psychotropic medications is excluded, except for antidepressants that have been taken at a stable dose for at least 2 weeks; * Active suicidal or homicidal ideation or suicide attempts within the past six months requiring hospitalization; * Subjects with significant nasal pathology (atrophic rhinitis, recurrent nose bleeds, or history of hypophysectomy); * Smokers who smoke more than 15 cigarettes per day; * Those who smoke cigarettes or have caffeine or alcohol within 24 hours of the study visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Cooperation | Day 1 (first day oxytocin or placebo was administered) | 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. |
| Disengagement From Social Threat Cues | Day 1 (first day oxytocin or placebo was administered) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Trust Scores on a 1-7 Likert Scale | Day 1 (first day oxytocin or placebo was administered) | 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. |
| Perceived Empathy Scores on a 1-7 Likert Scale | Day 1 (first day oxytocin or placebo was administered) | 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. |
| Perceived Preference Scores on a 1-7 Likert Scale | Day 1 (first day oxytocin or placebo was administered) | 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. |
| Perceived Rejection Scores on a 1-7 Likert Scale | Day 1 (first day oxytocin or placebo was administered) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once | 27 |
| Placebo Matched placebo nasal spray
Placebo: Matched placebo nasal spray | 27 |
| Total | 54 |
Baseline characteristics
| Characteristic | Oxytocin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 27 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 24 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 16 Participants | 35 Participants |
| Region of Enrollment United States | 27 participants | 27 participants | 54 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 27 Participants | 27 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 27 | 9 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
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.
Time frame: Day 1 (first day oxytocin or placebo was administered)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Disengagement From Social Threat Cues | 1.34 Milliseconds | Standard Deviation 36.79 |
| Placebo | Disengagement From Social Threat Cues | -2.69 Milliseconds | Standard Deviation 52.39 |
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.
Time frame: Day 1 (first day oxytocin or placebo was administered)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Social Cooperation | 4.42 Ball tosses | Standard Deviation 6.706 |
| Placebo | Social Cooperation | 4.69 Ball tosses | Standard Deviation 6.078 |
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.
Time frame: Day 1 (first day oxytocin or placebo was administered)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Perceived Empathy Scores on a 1-7 Likert Scale | 4.46 units on a scale | Standard Deviation 1.39 |
| Placebo | Perceived Empathy Scores on a 1-7 Likert Scale | 4.27 units on a scale | Standard Deviation 1.46 |
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.
Time frame: Day 1 (first day oxytocin or placebo was administered)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Perceived Preference Scores on a 1-7 Likert Scale | 5.04 units on a scale | Standard Deviation 1.4 |
| Placebo | Perceived Preference Scores on a 1-7 Likert Scale | 5.04 units on a scale | Standard Deviation 1.18 |
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.
Time frame: Day 1 (first day oxytocin or placebo was administered)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Perceived Rejection Scores on a 1-7 Likert Scale | 3.35 units on a scale | Standard Deviation 1.41 |
| Placebo | Perceived Rejection Scores on a 1-7 Likert Scale | 3.65 units on a scale | Standard Deviation 1.29 |
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.
Time frame: Day 1 (first day oxytocin or placebo was administered)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Perceived Trust Scores on a 1-7 Likert Scale | 4.65 units on a scale | Standard Deviation 1.47 |
| Placebo | Perceived Trust Scores on a 1-7 Likert Scale | 4.73 units on a scale | Standard Deviation 1.12 |