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Social IntelligenceNCT01551303

Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety

A study testing Oxytocin in people with Social Intelligence, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Social Intelligence
What is being tested?
Oxytocin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
1 siteUnited States
Study dates
Feb 2009to Dec 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Anxiety and Traumatic Stress Disorders (CATSD)

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Read the 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.

Being tested
Oxytocin, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxytocinDrug

    Also called Syntocinon

    Liquid metered-dose nasal spray, 30 IUs, administered once.

  • PlaceboDrug

    Matched nasal spray placebo

Study groups in NCT01551303
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMatched nasal spray placebo.
Receives: Drug: Placebo
OxytocinExperimentalLiquid intranasal oxytocin administered in a nasal spray.
Receives: Drug: Oxytocin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 minutes after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2012 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01551303
Sponsor's protocol ID
2009P-000387
Status last verified
Mar 2014
First submitted
21 Feb 2012
Last updated
30 Jun 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Oxytocin in people with Social Intelligence, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Affective Ratings in Affective Learning Task (time frame: 30 minutes after drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.

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