Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Social Intelligence |
Drug: Oxytocin Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety |
- Magnitude of interference on perception (see description) [ Time Frame: There is only one study visit; this is not a longitudnal study. Outcome measures (study measures) will be assessed during the single visit lasting 2-3 hours; testing occurs 30 minutes after drug administration ] [ Designated as safety issue: No ]We will measure the effect of the drug on affective misattribution, using the Continuous Flash Suppression Task. perceivers view dynamic visual images in one eye, while the other eye is presented with a still image. Participants experience seeing only the flashing dynamic images while the still image remains unseen, suppressed from conscious experience. Our task pairs an unseen emotionally expressive face with a consciously seen neutral face, and subjects are asked to rate the seen face in terms of competence, trustworthiness, and warmth, using a four-point scale for each. Thirty unique identities (faces) were presented; ten were paired with each type of suppressed face type (scowling, smiling, neutral) for a total 30 trials. These 30 trials were repeated in two blocks, so each identity was shown two times (always with the same suppressed facial expression, counterbalanced across participants) to yield 60 trials.
| Enrollment: | 47 |
| Study Start Date: | February 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Matched nasal spray placebo.
|
Drug: Placebo
Matched nasal spray placebo
Other Name: placebo
|
|
Experimental: Oxytocin
Liquid intranasal oxytocin administered in a nasal spray.
|
Drug: Oxytocin
Liquid metered-dose nasal spray, 30 IUs, administered once.
Other Name: Syntocinon
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- No current Axis I DSM-IV excluded diagnoses as determined by MINI or SCID 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.
Contacts and Locations| United States, Massachusetts | |
| Center for Anxiety and Traumatic Stress Disorders (CATSD) | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Elizabeth A Hoge, M.D. | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Elizabeth A. Hoge, MD, Assistant Psychiatrist, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01551303 History of Changes |
| Other Study ID Numbers: | 2009P-000387 |
| Study First Received: | February 21, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Oxytocin Oxytocics Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013