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
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551303

Locations
United States, Massachusetts
Center for Anxiety and Traumatic Stress Disorders (CATSD)
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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
Results First Received: March 26, 2014
Last Updated: May 29, 2014
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 August 28, 2014