Social Intelligence
Conditions
Brief summary
The purpose of this study is to learn more about how emotional processing may be affected by a hormone called oxytocin. Oxytocin is a hormone that occurs naturally in the body, and may play an important role in the way that the brain perceives information.
Detailed description
Extensive research has been conducted to examine cognitive styles in anxiety disorders that may contribute to the psychopathology of these disorders. One of the most consistent findings has been that anxious subjects attend preferentially to threatening stimuli. This attentional bias, which would increase time spent attending to and processing threatening stimuli such as words, sentences, or faces, is thought to help provoke and maintain anxiety states. This is supported by research that demonstrates that reduction in anxiety symptoms is associated with a decrease in attentional bias. Related to an attentional bias is the concept of a perceptual bias, from which people with anxiety disorders may be more perceptive to negative emotional cues. For example, Duncan and Barrett (2007) found a negative correlation between objective awareness of quickly presented faces depicting fear and extraversion. Participants who reported greater extraversion (i.e., pleasure derived from social interactions) were less likely to see 16 ms presentations of faces depicting fear. Thus, it appears that how someone feels is related to and may influence the information they see in their environment. The investigators thus hypothesize that the presence of chronic anxiety disorders may be linked to perceptual biases, and may actually influence how and what information they perceive (their sensory experience). People with anxiety disorders may be less likely to see positive objects and more likely to see negative objects. Although the neurobiological mechanisms underlying these anxiety disorders remain uncertain, one hypothesis implicates the dysregulation of the neuropeptide oxytocin. Oxytocin is a nine-amino-acid peptide which has a role in maintaining social behavior, and it has been found to decrease anxiety. Researchers have postulated that the anti-anxiety affects of oxytocin are related to the trust and pro-approach behaviors associated with this peptide. For example, mice treated with oxytocin spend more time in the previously avoided open areas of a maze. In a study in humans using healthy volunteers, participants were administered oxytocin or placebo before they played a game with monetary rewards involving trust with a stranger. Those who received oxytocin transferred higher amounts of money to the other player than those who received placebo. This behavior, involving increased comfort with a novel individual or setting, appears to be related to the effects of oxytocin. As described above, individuals with high levels of anxiety have a perception bias towards emotional stimuli, such as pictures of faces. Oxytocin's anxiolytic, pro-approach and trust effects may decrease this bias, and may cause an individual to experience people or things in the environment as less threatening.
Interventions
DRUGOxytocin
Liquid metered-dose nasal spray, 30 IUs, administered once.
DRUGPlacebo
Matched nasal spray placebo
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* No current Axis I according to Diagnostic & Statistical Manual for Psychiatry-IV excluded diagnoses as determined by MINI or Structured Clinical Interview for Diagnosis psychiatric diagnostic interview completed within the past 6 months * Age 18 to 65 * Subjects must be able to give informed consent and be willing and able to comply with study procedures.
Exclusion criteria
* Patients with severe unstable medical illness, clinically significant laboratory findings, or serious medical illness for which hospitalization may be likely within the next three months * Pregnant or lactating women. * Subjects currently taking hormones, such as estrogen. * Known hypersensitivity to oxytocin or to any of the excipients of Syntocinon Nasal spray. * Known hyponatremia or concurrent use of diuretics. * Subjects with a history of seizure disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Affective Ratings in Affective Learning Task | 30 minutes after drug administration | We will measure the effect of the drug on affective learning, using the Affective Learning Task. Participants viewed 30 neutral faces, each paired with one sentence describing a negative positive, or neutral behavior, counterbalanced across participants. During the test phase, participants will rate the faces as negative, neutral, or positive. These ratings were averaged. Responses were coded as: negative = -1, neutral = 0, positive =1, so the averaged scores have a possible range between -1 and 1. Since this is not a treatment study for a disease, there is so better or worse outcome. |
Countries
United States
Participant flow
Recruitment details
Adults aged 18 to 65 were recruited to the Massachusetts General Hospital through local email and print media advertising from March 2011 to September 2011.
Pre-assignment details
No enrolled participants were excluded before group assignment.
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin Oxytocin, 30 IU in 0.77 ml, intranasal | 25 |
| Placebo Placebo, 0.77 ml, intranasal | 22 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | failed awareness check on vision test | 4 | 7 |
Baseline characteristics
| Characteristic | Oxytocin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 42.24 years STANDARD_DEVIATION 11.61 | 44.50 years STANDARD_DEVIATION 9.62 | 43.30 years STANDARD_DEVIATION 10.67 |
| Region of Enrollment United States | 25 participants | 22 participants | 47 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 1 / 25 |
| serious Total, serious adverse events | 0 / 22 | 0 / 25 |
Outcome results
Primary
Affective Ratings in Affective Learning Task
We will measure the effect of the drug on affective learning, using the Affective Learning Task. Participants viewed 30 neutral faces, each paired with one sentence describing a negative positive, or neutral behavior, counterbalanced across participants. During the test phase, participants will rate the faces as negative, neutral, or positive. These ratings were averaged. Responses were coded as: negative = -1, neutral = 0, positive =1, so the averaged scores have a possible range between -1 and 1. Since this is not a treatment study for a disease, there is so better or worse outcome.
Time frame: 30 minutes after drug administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Affective Ratings in Affective Learning Task | -0.096 units on a scale | Standard Error 0.05 |
| Placebo | Affective Ratings in Affective Learning Task | -0.12 units on a scale | Standard Error 0.054 |