Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01551303
First received: February 21, 2012
Last updated: May 29, 2014
Last verified: March 2014

February 21, 2012
May 29, 2014
February 2009
December 2012   (final data collection date for primary outcome measure)
Affective Ratings in Affective Learning Task [ Time Frame: 30 minutes after drug administration ] [ Designated as safety issue: No ]
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.
Magnitude of interference on perception (see description) [ Time Frame: Outcome 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 how the drug vs. placebo may change the way that information is processed in the brain, when different visual information is presented to each eye; specifically, we will ask participants to rate what they saw, and see to what degree the information from both eyes was used.
Complete list of historical versions of study NCT01551303 on ClinicalTrials.gov Archive Site
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Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety
Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Social Intelligence
  • Drug: Oxytocin
    Liquid metered-dose nasal spray, 30 IUs, administered once.
    Other Name: Syntocinon
  • Drug: Placebo
    Matched nasal spray placebo
    Other Name: placebo
  • Placebo Comparator: Placebo
    Matched nasal spray placebo.
    Intervention: Drug: Placebo
  • Experimental: Oxytocin
    Liquid intranasal oxytocin administered in a nasal spray.
    Intervention: Drug: Oxytocin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01551303
2009P-000387
No
Elizabeth A. Hoge, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Elizabeth A Hoge, M.D. Massachusetts General Hospital
Massachusetts General Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP